{
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      "@container": "@list"
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    "supported": "au:supported",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0706-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)\tXS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)\tXS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)\tXS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)\tXS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)\tXS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)\tXS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)\tXS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX;  s)\tXS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB;  t)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB;  u)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB;  v)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA;  w)\tXS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB;  x)\tXS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX;  y)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA;  z)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB;  aa)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA;  bb)\tXS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA;  cc)\tXS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX;  dd)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA;  ee)\tXS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA;  ff)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB;  gg)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA;  hh)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB;  ii)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC;  jj)\tXS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA;  kk)\tXS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX;  ll)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB;  mm)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX;  nn)\tXS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA;  oo)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB;  pp)\tXS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC;  qq)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA;  rr)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA;  ss)\tXS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA;  tt)\tXS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB;  uu)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX;  vv)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX;  ww)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX;  xx)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX;  yy)\tXS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA;  zz)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX;  aaa)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA;  bbb)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA;  ccc)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX;  ddd)\tXS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB;  eee)\tXS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC;  fff)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX;  ggg)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA;  hhh)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX;  iii)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA;  jjj)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB;  kkk)\tXS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX;  lll)\tXS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA;  mmm)\tXS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB;  nnn)\tXS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA;  ooo)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA;  ppp)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA;  qqq)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB;  rrr)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB;  sss)\tXS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA;  ttt)\tXS6 WAM TTL KIT BCRT IEC",
  "description": "FDA recall Z-0706-2024 — Baxter Healthcare Corporation is recalling XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)\tXS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)\tXS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)\tXS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)\tXS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)\tXS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)\tXS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)\tXS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX;  s)\tXS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB;  t)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB;  u)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB;  v)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA;  w)\tXS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB;  x)\tXS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX;  y)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA;  z)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB;  aa)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA;  bb)\tXS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA;  cc)\tXS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX;  dd)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA;  ee)\tXS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA;  ff)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB;  gg)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA;  hh)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB;  ii)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC;  jj)\tXS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA;  kk)\tXS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX;  ll)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB;  mm)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX;  nn)\tXS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA;  oo)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB;  pp)\tXS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC;  qq)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA;  rr)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA;  ss)\tXS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA;  tt)\tXS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB;  uu)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX;  vv)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX;  ww)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX;  xx)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX;  yy)\tXS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA;  zz)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX;  aaa)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA;  bbb)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA;  ccc)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX;  ddd)\tXS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB;  eee)\tXS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC;  fff)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX;  ggg)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA;  hhh)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX;  iii)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA;  jjj)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB;  kkk)\tXS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX;  lll)\tXS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA;  mmm)\tXS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB;  nnn)\tXS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA;  ooo)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA;  ppp)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA;  qqq)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB;  rrr)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB;  sss)\tXS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA;  ttt)\tXS6 WAM TTL KIT BCRT IEC (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0706-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)\tXS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)\tXS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)\tXS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)\tXS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)\tXS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)\tXS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)\tXS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX;  s)\tXS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB;  t)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB;  u)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB;  v)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA;  w)\tXS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB;  x)\tXS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX;  y)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA;  z)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB;  aa)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA;  bb)\tXS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA;  cc)\tXS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX;  dd)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA;  ee)\tXS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA;  ff)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB;  gg)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA;  hh)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB;  ii)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC;  jj)\tXS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA;  kk)\tXS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX;  ll)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB;  mm)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX;  nn)\tXS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA;  oo)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB;  pp)\tXS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC;  qq)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA;  rr)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA;  ss)\tXS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA;  tt)\tXS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB;  uu)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX;  vv)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX;  ww)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX;  xx)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX;  yy)\tXS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA;  zz)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX;  aaa)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA;  bbb)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA;  ccc)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX;  ddd)\tXS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB;  eee)\tXS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC;  fff)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX;  ggg)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA;  hhh)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX;  iii)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA;  jjj)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB;  kkk)\tXS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX;  lll)\tXS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA;  mmm)\tXS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB;  nnn)\tXS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA;  ooo)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA;  ppp)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA;  qqq)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB;  rrr)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB;  sss)\tXS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA;  ttt)\tXS6 WAM TTL KIT BCRT IEC",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Baxter Healthcare Corporation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0706-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0706-2024: Baxter Healthcare Corporation is recalling XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)\tXS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)\tXS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)\tXS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)\tXS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)\tXS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)\tXS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)\tXS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX;  s)\tXS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB;  t)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB;  u)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB;  v)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA;  w)\tXS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB;  x)\tXS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX;  y)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA;  z)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB;  aa)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA;  bb)\tXS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA;  cc)\tXS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX;  dd)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA;  ee)\tXS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA;  ff)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB;  gg)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA;  hh)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB;  ii)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC;  jj)\tXS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA;  kk)\tXS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX;  ll)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB;  mm)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX;  nn)\tXS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA;  oo)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB;  pp)\tXS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC;  qq)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA;  rr)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA;  ss)\tXS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA;  tt)\tXS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB;  uu)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX;  vv)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX;  ww)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX;  xx)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX;  yy)\tXS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA;  zz)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX;  aaa)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA;  bbb)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA;  ccc)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX;  ddd)\tXS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB;  eee)\tXS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC;  fff)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX;  ggg)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA;  hhh)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX;  iii)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA;  jjj)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB;  kkk)\tXS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX;  lll)\tXS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA;  mmm)\tXS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB;  nnn)\tXS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA;  ooo)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA;  ppp)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA;  qqq)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB;  rrr)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB;  sss)\tXS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA;  ttt)\tXS6 WAM TTL KIT BCRT IEC",
      "text": "The FDA logged enforcement record Z-0706-2024: Baxter Healthcare Corporation is voluntarily recalling XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)\tXS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)\tXS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)\tXS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)\tXS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)\tXS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)\tXS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)\tXS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)\tXS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX;  s)\tXS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB;  t)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB;  u)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB;  v)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA;  w)\tXS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB;  x)\tXS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX;  y)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA;  z)\tXS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB;  aa)\tXS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA;  bb)\tXS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA;  cc)\tXS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX;  dd)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA;  ee)\tXS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA;  ff)\tXS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB;  gg)\tXS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA;  hh)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB;  ii)\tXS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC;  jj)\tXS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA;  kk)\tXS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX;  ll)\tXS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB;  mm)\tXS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX;  nn)\tXS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA;  oo)\tXS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB;  pp)\tXS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC;  qq)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA;  rr)\tXS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA;  ss)\tXS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA;  tt)\tXS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB;  uu)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX;  vv)\tXS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX;  ww)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX;  xx)\tXS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX;  yy)\tXS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA;  zz)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX;  aaa)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA;  bbb)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA;  ccc)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX;  ddd)\tXS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB;  eee)\tXS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC;  fff)\tXS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX;  ggg)\tXS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA;  hhh)\tXS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX;  iii)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA;  jjj)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB;  kkk)\tXS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX;  lll)\tXS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA;  mmm)\tXS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB;  nnn)\tXS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA;  ooo)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA;  ppp)\tXS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA;  qqq)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB;  rrr)\tXS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB;  sss)\tXS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA;  ttt)\tXS6 WAM TTL KIT BCRT IEC — reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-08. Affected lots/codes: Product Code, UDI/DI Number, Serial Numbers  a) 41000-030-50, UDI/DI None, Serial Numbers:  110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242, 111340091243, 111360092140, 111360092141, 111360092142, 111360092143, 111360092144, 111340091246, 111340091247, 111340091248, 111340091249, 111340091250, 111420097839, 111420097840, 111420097841, 111420097842, 111420097843, 111500103083, 111500103084, 111500103085, 111500103086, 111530104948, 111530104949, 111530104950, 111530104951, 112020106363, 112020106364, 112020106365, 112020106366, 112020106367, 112020106368, 112020106369, 112020106370, 112180115629, 112180115630, 112180115631, 112180115632, 112180115633, 112180115634, 112180115635, 112200117094, 112200117095, 112200117096, 112200117097, 112200117098, 112200117099, 112200117100, 112200117101, 112200117102, 112200117103, 112320128027, 112320128028, 112320128029, 112320128030, 112320128031, 112350130930, 112350130931, 112350130932, 112350130933, 112350130934, 112350130935, 112350130936, 112350130937, 112440138921, 112440138922, 112440138923, 112440138924, 112440138925, 112440138926, 112440138927, 112440138928, 112440138929, 112440138930, 112440138931, 112440138932, 113010147090, 113010147091, 113010147092, 113010147093, 113070153116, 113070153117, 113070153118, 113070153119, 113070153120, 113070153121, 113070153122, 113070153123, 113070153124, 113070153125, 113070153126, 113070153127, 113070153128, 113070153129, 113270168996, 113270168997, 113270168998, 113270168999, 113270169000, 113310172113, 113310172114, 113310172115, 113310172116, 113350174038, 113350174039, 113350174040, 113350174041, 113350174046, 113350174047, 113350174042, 113350174043, 113350174044, 113350174045, 113410177775, 113410177776, 113410177777, 113410177778, 113410177779, 113410177780, 113410177781, 113440180951, 113440180952, 113440180953, 113470184299, 113470184300, 113470184301, 113530189429, 113530189430, 113530189431, 113530189432, 113530189433, 113530189434, 114050192901, 114050192902, 114050192903, 114090196065, 114090196066, 114090196067, 113460182788, 113460182789, 113460182790, 113460182791, 113460182792, 113460182793, 114420232656, 114420232657, 114420232658, 114420232659, 114420232660, 114420232661, 114480237409, 114480237410, 114420232662, 114420232663, 114420232664, 114420232665, 114520240984, 114520240985, 114520240986, 114520240987, 114520240988, 114520240989, 115050243901, 115050243902, 115050243903, 114470236646, 114470236647, 114470236648, 115230258572, 115230258573, 115230258574, 115230258575, 115230258576, 115230258424, 115230258425, 115230258426, 115280263454, 115280263455, 115280263456, 115280263457, 115280263458, 115280263459, 115280264206, 115280264207, 115280264208, 115280264209, 115280264210, 115280264211, 115330268899, 115330268900, 115330268901, 115330268902, 115330268903, 115330268904, 115400275479, 115400275480, 115400275481, 115400275482, 115400275483, 115400275484, 115400275485, 115400275486, 115400275487, 115400275488, 116020287198, 116020287199, 116020287200, 116100335156, 116100335157, 116100335158, 116130382423, 116130382424, 116130382425, 116130382426, 116130382427, 116180422043, 116180422044, 116180422045, 116180422046, 116180422047, 116240477718, 116240477719, 116240477720, 116240477721, 116270497993, 116270497994, 116270497995, 116270497996, 116380527123, 116380527124, 116380527125, 116380527126, 116380527127, 116380527128, 116380527129, 116380527130;  b) 41000-030-51, UDI/DI None, Serial Numbers:  110120039425, 110120039426, 110120039427, 110190044568, 110190044569, 110190044570, 110200045836, 110200045837, 110200045838, 110330056675, 110330056676, 110370059009, 110370059010, 110370059011, 110390059824, 110420060941, 110420060942, 110500066898, 110500066899, 110500066900, 111060071714, 111060071715, 111060071716, 111150077462, 111150077463, 111200081342, 111200081343, 111270086404, 111270086405, 111270086406, 111270086407, 111380093553, 111380093554, 111380093555, 111380093556, 111380093557, 111470101214, 111470101215, 111500103087, 111500103088, 111500103089, 112030106627, 112030106628, 112050108028, 112050108029, 112100110764, 112100110765, 112050108026, 112050108027, 112220118711, 112220118712, 112220118713, 112270124286, 112270124287, 112270124288, 112320128032, 112320128033, 112320128034, 112410137135, 112410137136, 112410137137, 112440139667, 112440139668, 112440138933, 112440138934, 112440138935, 112440138936, 112440138937, 112440138938, 113020147730, 113020147731, 113020147732, 113020147733, 113020147734, 113020147735, 113020147736, 113020147737, 113130159216, 113130159217, 113130159218, 113130159219, 113130159220, 113130159221, 113130159222, 113130159223, 113130159224, 113130159225, 113130159226, 113130159227, 113130159228, 113130159229, 113130159230, 113450181907, 113450181908, 113480185307, 113480185308, 113450181644, 113450181645, 113450181646, 113450181647, 113450181648, 113450181649, 113450181650, 113450181651, 113450181652, 113450181653, 114380229638, 114380229639, 114440234317, 114440234325, 114470236649, 114470236650, 114480237351, 114480237352, 114480237353, 114480237354, 114480237349, 114480237350, 115060244042, 115060244043, 115100247551, 115100247552, 115100247553, 115140251901, 115140251902, 115140251903, 115140251904, 115140251905, 115140251906, 115140251907, 115140251908, 115200256104, 115200256105, 115230258565, 115230258566, 115230258567, 115230258568, 115240258971, 115240258972, 115240258973, 115240258974, 115200256100, 115200256101, 115200256102, 115200256103, 116020287201, 116020287202, 116050291262, 116050291263, 116100335159, 116100335160, 116140387942, 116140387943, 116140387944, 116180423551, 116180423552;  c) 41000-030-52, UDI/DI None, Serial Numbers:  110120039363, 110120039364, 110230049218, 110230049219, 110230049220, 110230049221, 110280053721, 110280053722, 110280053723, 110280053724, 110280053725, 110330056793, 110330056794, 110370059012, 110370059013, 110370059014, 110410060508, 110410060509, 110410060510, 110410060511, 110440063042, 110440063043, 110440063044, 110440063045, 110460064750, 110460064751, 110460064752, 110460064707, 110460064708, 110460064709, 110460064710, 110460064711, 110460064712, 110460064713, 110460064714, 111060071710, 111060071711, 111060071712, 111060071713, 111200081535, 111200081536, 111200081537, 111230083963, 111230083964, 111230083965, 111330090559, 111330090560, 111330090561, 111330090562, 111330090563, 111330090564, 111330090565, 111450099468, 111450099469, 111450099470, 111450099471, 111450099472, 111450099473, 111450099474, 111450099475, 111460100779, 111460100780, 111460100781, 111490102399, 111490102400, 111490102401, 111460100426, 111460100427, 111460100428, 112020105816, 112020105817, 112020105818, 112020105819, 112020105820, 112020105821, 112130112152, 112130112153, 112130112154, 112130112155, 112130112156, 112130112157, 112280125032, 112280125033, 112280125034, 112280125035, 112280125036, 112280125037, 112250123314, 112250123315, 112250123316, 112250123317, 113100155571, 113100155572, 113130159201, 113130159202, 113130159203, 113130159204, 113130159205, 113130159206, 113130159207, 113130159208, 113130159209, 113130159210, 113130159211, 113130159212, 113130159213, 113130159214, 113130159215, 114020190211, 114020190212, 114020190213, 114020190214, 114020190215, 114020190216, 114020190217, 114180209245, 114180209246, 114020190218, 114020190219, 114180209247, 114180209248, 114180209249, 114180209250, 114180209251, 114180209252, 114250218419, 114460236532, 114460236533, 114460236534, 114460236529, 114460236530, 114460236531, 114460236526, 114460236527, 114460236528, 115260260562, 115260260563, 115260260564, 115360271118, 115360271119, 115360271120, 115440278666, 115440278667, 115440278668, 115500283264, 115500283265, 115500283266, 116050290129, 116050290130, 116050290131, 116050290132, 116110349285, 116110349286, 116110349287, 116110349288, 116110349289, 116200433074, 116200433075, 116230452680, 116230452681, 116230452682, 116280504772, 116280504773, 116280504774;  d) 41000-030-53, UDI/DI None, Serial Numbers:  110120039428, 110120039429, 110120039430, 110120039431, 110120039432, 110120039433, 110120039434, 110120039435, 110120039436;  e) 41000-030-60, UDI/DI 00817655020051, Serial Numbers:  118060611436, 118060611438, 118060611439, 118080615013, 118080615022, 118180634934, 118080615011, 118180634932, 118180634933, 118180634936, 118060611447, 118080615017, 118080615018, 118080615021, 118080615019, 118080615020, 118180634938, 118180634939, 118180634940, 118160628568, 118160628569, 118160628570, 118180634931, 118180634935, 118160628577, 118160628578, 118160628579, 118160628580, 118160628581, 118160628583, 118160628564, 118160628565, 118160628566, 118160628567, 118160628571, 118160628572, 118160628573, 118160628582, 118160628574, 118160628575, 118160628576, 118340001391, 118340001392, 118340001393, 118340001394, 118340001395, 118340001396, 118340001397, 118340001388, 118340001389, 118340001390, 119110000129, 119110000130, 119110000132, 119110000133, 119110000134, 119110000135, 119110000136, 119110000137, 119130001327, 119130001328, 119130001331, 119110000128, 119110000131, 119130001329, 119130001330, 119170000064, 119170000066, 119170000067, 119170000068, 119190000633, 119190000634, 119190000635, 119190000629, 119190000630, 119190000636, 119190000637, 119170000054, 119170000061, 119190000628, 119190000631, 119190000632, 119170000055, 119170000056, 119170000062, 119170000063, 119170000065, 119170000057, 119170000058, 119170000059, 119170000060, 119240001197, 119240001198, 119340000071, 119340000072, 119340000073, 119340000074, 119340000075, 119340000076, 119340000077, 119340000078, 119340000079, 119340000080, 119350002675, 119350002676, 119350002677, 119350002678, 119350002679, 119350002680, 119350002681, 119350002682, 119350002683, 119350002684, 119380001144, 119380001145, 119380001146, 119380001147, 119380001148, 119380001149, 119430001324, 119430001325, 119430001326, 119430001327, 119430001328, 119430001329, 119430001330, 119430001331, 119430001332, 119430001333, 119470001107, 119470001108, 119470001109, 119470001110, 119470001111, 119470001112, 119470001113, 119470001114, 119470001115, 119470001116, 119500000427, 119500000428, 119500000429, 119500000430, 119500000431, 119500000432, 119500000433, 119500000434, 120080000436, 120080000437, 120080000438, 120080000439, 120080000440, 120080000441, 120080000442, 120080000443, 120080000444, 120080000445, 120080000446, 120080000447, 120080000448, 120080000449, 120080000450, 120080000451, 120080000452, 120080000453, 120080000454, 120080000455, 120260000436, 120260000437, 120260000438, 120370001869, 120370001870, 120370001872, 120260000439, 120260000440, 120370001871, 120370001873, 120370001874, 120370001875, 120370001876, 120370001877, 120370001878, 120410001420, 120410001421, 120410001422, 120410001423, 120410001424, 120410001425, 120410001426, 120410001427, 120480000382, 120480000383, 120480000384, 120480000385, 120480000386, 120480000387, 120480000388, 120480000389, 120480000390, 120480000391, 120480000392, 120480000393, 120480000394, 120480000395, 120520000178, 120520000179, 120520000180, 120520000181, 120520000182, 120520000183, 120520000184, 120520000185, 120520000186, 120520000187, 120520000188, 120520000189, 121060001022, 121060001023, 121060001024, 121060001025, 121060001026, 121060001027, 121060001028, 121060001029, 121060001030, 121060001031, 121080000918, 121080000919, 121080000920, 121080000921, 121080000922, 121080000923, 121080000924, 121130001105, 121130001106, 121130001107, 121130001108, 121130001109, 121130001110, 121130001111, 121130001112, 121130001113, 121130001114, 121130001115, 121130001116, 121130001117, 121130001118, 121130001119, 121140001520, 121140001521, 121140001522, 121140001523, 121140001524, 121170000316, 121170000317, 121170000318, 121170000319, 121170000320, 121170000321, 121170000322, 121170000323, 121170000324, 121170000325, 118050609197, 121210002553, 121210002554, 121210002555, 121210002556, 121210002557, 121210002558, 121210002559, 121210002560, 121210002561, 121210002562, 121250000651, 121250000652, 121250000653, 121250000654, 121250000655, 121250000656, 121250000657, 121250000658, 121250000659, 121250000660, 121250000661, 121250000662, 121300001879, 121300001880, 121300001881, 121300001882, 121300001883, 121300001884, 121300001885, 121300001886, 121300001887, 121300001888, 121320000722, 121320000723, 121320000724, 121320000725, 121320000726, 121320000727, 121320000728, 121320000729, 121390000580, 121390000581, 121390000582, 121390000583, 121390000584, 121390000585, 121390000586, 121390000587, 121390000588, 121390000589, 121390000590, 121390000591, 121430000457, 121430000458, 121430000459, 121430000460, 121430000461, 121430000462, 121430000463, 121430000464, 121430000465, 121430000466, 121430000467, 121430000468, 121450000127, 121450000128, 121460000618, 121490000525, 121490000526, 121490000527, 121490000528, 121490000529, 121490000530, 121490000531, 121490000532, 121490000533, 121490000534, 121490000535, 121490000536, 122130000539, 122130000540, 122130000541, 122130000542, 122130000543, 122130000544, 122130000545, 122130000546, 122190000029, 122190000030, 122190000031, 122190000032, 122190000033, 122190000034, 122200001921, 122200001922, 122200001923, 122200001924, 122200001925, 122200001926, 122200001927, 122200001928, 122200001929, 122200001930, 122200001931, 12200001930, 122240001466, 122240001467, 122240001468, 122240001469, 122240001470, 122240001471, 122230000033, 122230000036, 122230000039, 122230000040, 122230000042, 122230000044, 122230000037, 122230000038, 122230000041, 122230000043, 122230000034, 122260001174, 122260001175, 122260001176, 122260001177, 122260001178, 122260001179, 122280000876, 122280000877, 122280000878, 122280000879, 122280000880, 122280000881, 122340001204, 122340001205, 122340001206, 122340001207, 122390000370, 122390000371, 122390000372, 122390000373, 122390000374, 122390000375, 122420000196, 122420000197, 122420000198, 122420000199, 122420000200, 122420000203, 122420000192, 122420000193, 122420000194, 122420000195, 122420000201, 122420000202, 122450001786, 122450001787, 122450001788, 122450001789, 122450001790, 122450001791, 123100000063, 123100000069, 123100000070, 123100000071, 123100000064, 123100000065, 123100000066, 123100000067, 123100000068, 123130001066, 123130001067, 123210000710, 123210000711, 123340001553, 123340001554, 123320000551, 123320000552, 123370000077, 123370000078, 123370000079, 123370000080, 118050610039, 118180634937, 118050609198, 118180634937, 121450000127, 121450000128, 121460000618, 122230000033, 122230000034, 122230000035, 122230000036, 122230000037, 122230000038, 122230000039, 122230000040, 122230000041, 122230000042, 122230000043, 122230000044, 122500000829, 122500000830, 122500000831, 116480540886, 116480540887, 116480540885, 116480540888, 116480540889, 116480540890, 116480540891, 116500543972, 116530547195, 116530547196, 116530547197, 116530547198, 116530547199, 116530547200, 116530547201, 116530547207, 116530547208, 116530547209, 116530547202, 116530547203, 116530547204, 116530547205, 116530547206, 117050552991, 117050552992, 117140561292, 117140561293, 117140561294, 117140561295, 117140561296, 117140561297, 117140561299, 117140561300, 117140561301, 117140561302, 117190567099, 117190567100, 117140561298, 117190567101, 117190567102, 117190567103, 117190567104, 117190568321, 117190568322, 117190568323, 117210570066, 117250575592, 117250575593, 117250575594, 117250575595, 117250575596, 117250575597, 117260576261, 117260576262, 117260576263, 117250575598, 117250575599, 117250575600, 117250575601, 117310581178, 117310581179, 117350584646, 117350584647, 117350584648, 117350584649, 117350584650, 117350584642, 117350584643, 117400589264, 117400589265, 117400589266, 117400589267, 117400589268, 117400589293, 117400589294, 117400589295, 117400589296, 117400589297, 117400589298, 117400589299, 117400589269, 117400589270, 117400589271, 117400589272, 117400589273, 117400589274, 117430591637, 117430591638, 117430591639, 117430591640, 117430591980, 117430591981, 117490599622, 117490599623, 117490599624, 117490599625, 117490599627, 117490599628, 117490599630, 117490599619, 117490599620, 117490599621, 117490599626, 117490599629, 117490599631, 117490599632, 117490599633, 117510602851, 117510602852, 117510602853, 117510602854, 117520603151, 117520603152, 117520603153, 117520603154, 118030606983, 118030606984, 118030606985, 118030606986, 118030606987, 118030606988, 118030606989, 118030606990, 118030606991, 118030606992, 118050609193, 118050609194, 118050609195, 118050609196, 118050609199, 118050609200, 118050609201, 118050609202, 118060611433, 118060611429, 118060611430, 118060611431, 118060611432, 118060611434, 118060611435, 118060611437, 118060611440, 118080615016, 118080615015, 118080615014, 118080615012, 118080615010, 118080615009, 118080615008, 118080615007, 118080615006, 118080615005, 118080615004, 118080615003, 118060611448, 118060611446, 118060611445, 118060611444, 118060611443, 118060611442, 118060611441, 41000-030-60, 118180634941, 118180634942, 118340001398, 118340001399, 118340001400, 118340001401, 118340001402, 118340001403, 118340001404, 118340001405, 118340001406, 118340001407, 118340001408, 118340001409, 118340001410, 118340001411, 118340001412, 120180001027, 120180001028, 120180001029, 120180001030, 120180001031, 10081765502005100, 121040002235, 121040002236, 121040002237, 121040002238, 121040002239, 121040002240, 121040002241, 121040002242, 121040002243, 121040002244, 121050001674, 121050001675, 121050001676, 121050001677, 121050001678, 121050001679, 121050001680, 121050001681, 121050001682, 121050001683, 121080000925, 121080000926, 121080000927, 122200001932, 10081765502005100, 123390000815, 123390000816, 123390000817, 123390000818, 123400000181, 123400000182, 123400000183, 123400000184, 123420000969, 123420000970, 123420000971, 123420000972, 123430002087, 123440000214, 123440000215, 123440000216, 123440000217, 123450001456, 123450001457, 123450001458, 123450001459, 123480000269, 123480000270, 123480000271, 123480000272;  f) 41000-030-62, UDI/DI 00817655020068, Serial Numbers:  118160628584, 118160628585, 118320000033, 118330000323, 118330000325, 118320000032, 118330000324, 118330000326, 118330000320, 118330000321, 118330000322, 118450000081, 118450000082, 118330000319, 118470000102, 118470000406, 118470000407, 118470000408, 118480000446, 118480000447, 118480000448, 118480000449, 118500001826, 118500001827, 118500001834, 118500001835, 118500001828, 118500001830, 118500001829, 118500001831, 118500001832, 119190000641, 119190000642, 119190000638, 119190000639, 119190000640, 118500001825, 118500001833, 119250001407, 119320001005, 119320001006, 119320001007, 119320001002, 119320001003, 119320001004, 119350002522, 119350002523, 119350002524, 119350002525, 119430001320, 119430001321, 119430001322, 119430001323, 119430001318, 119430001319, 119470002142, 119470002144, 119470002146, 119470002143, 119470002145, 119470002147, 120040000343, 120040000344, 120050001743, 120050001744, 120050001745, 120080000456, 120080000457, 120080000458, 120080000459, 120080000460, 120080000461, 120080000462, 120080000463, 120080000464, 120080000465, 120080000466, 120080000467, 120080000468, 120080000469, 120080000470, 120080000471, 120080000472, 120080000473, 120080000474, 120330000674, 120330000676, 120050001744, 120050001745, 120330000671, 120330000672, 120330000673, 120330000675, 120330000677, 120330000678, 120330000679, 120330000680, 120050001743, 120480000397, 120480000396, 120520000680, 120520000681, 120520000682, 121060001019, 121060001020, 121060001021, 121080000928, 121080000929, 121130001120, 121130001121, 121130001122, 121170000326, 121170000327, 121170000328, 121210002563, 121210002564, 121210002565, 121250000663, 121250000664, 121250000665, 121300001889, 121300001890, 121300001891, 121340000858, 121340000859, 121340000860, 121420001162, 121420001163, 121420001164, 121420001165, 121470000236, 121470000237, 121470000238, 121510001415, 121510001416, 121510001417, 122050001914, 122050001915, 122050001916, 122080000224, 122080000225, 122080000226, 122130000547, 122130000548, 122130000549, 122240001057, 122240001061, 122240001062, 122240001058, 122240001059, 122240001060, 122240001063, 122310000395, 122310000396, 122310000397, 122320000145, 122320000146, 122320000147, 122320000881, 122320000882, 122320000883, 122380000624, 122380000625, 122380000626, 122450001792, 122450001793, 122450001794, 122480001906, 122480001909, 123020001482, 123020001483, 123070001510, 123070001513, 123070001514, 123070001515, 123100001935, 123100001936, 123070001509, 123070001511, 123070001512, 123190000747, 123190000749, 123150002638, 123190000748, 123200000231, 123150002639, 123220001435, 123220001436, 123300001463, 123300001464, 123300000098, 123300000099, 123370000075, 123370000076, 122480001907, 122480001908, 123320000988, 123300001462, 123320000989, 123320000986, 123320000987, 120050001743, 120050001744, 120050001745, 120330000674, 120330000676, 120480000396, 113400177568, 116480540898, 116530547192, 116530547193, 116530547194, 117010549589, 117010549590, 117110556514, 117110556515, 117110556516, 117130560456, 117130560457, 117130560458, 117150562750, 117150562748, 117150562749, 117180567076, 117180567077, 117190568320, 117210570063, 117210570064, 117210570065, 117260575996, 117260575997, 117260575998, 117310581180, 117310581181, 117350584629, 117350584630, 117350584631, 117350584632, 117350584633, 117400589290, 117400589291, 117400589292, 117430592542, 117430592543, 117430592544, 117490599636, 117490599637, 117490599639, 117490599634, 117490599635, 117490599638, 118070612685, 118070612687, 118070612686, 118080614439, 118080614440, 118090617067, 118090617068, 118090617071, 118090617070, 118090617069, 118160628588, 118160628587, 118160628586, 118160628589, 118160628590, 118320000034, 118320000035, 118330000327, 118330000328, 118330000329, 120040000345, 120040000346, 120040000347, 120480000398, 120480000399, 120480000400, 120480000401, 120480000402, 120480000403, 120480000404, 120480000405, 120480000406, 120480000407, 120480000408, 123400000068, 123400000069;  g) 41000-030-64, UDI/DI 00817655021423, Serial Numbers:  119490000440, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 118380003022, 118380003023, 118470000103, 118470000104, 119500001336, 118380003022, 118380003023, 118470000103, 118470000104, 120070000731, 123150002068, 123150002069, 123150002070, 123160000556, 123150002055, 123200001669, 123150002057, 123150002058, 123200001670, 123200001671, 123150002066, 123150002067, 120070000733, 123150002056, 123150002061, 123150002062, 123150002063, 123150002064, 123150002065, 123150002059, 123150002060, 123160000552, 123160000553, 123160000554, 123160000555, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 117320582006, 120070000734, 120070000735, 120070000736, 120070000737, 11847000104, 120070000738, 120070000739, 121350001044, 121350001045.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0706-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0706-2024&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0706-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0706-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0706-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0706-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0706-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0706-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0706-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Baxter Healthcare Corporation",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-12-08",
            "Status": "recorded"
          }
        },
        {
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110120039431, 110120039432, 110120039433, 110120039434, 110120039435, 110120039436;  e) 41000-030-60, UDI/DI 00817655020051, Serial Numbers:  118060611436, 118060611438, 118060611439, 118080615013, 118080615022, 118180634934, 118080615011, 118180634932, 118180634933, 118180634936, 118060611447, 118080615017, 118080615018, 118080615021, 118080615019, 118080615020, 118180634938, 118180634939, 118180634940, 118160628568, 118160628569, 118160628570, 118180634931, 118180634935, 118160628577, 118160628578, 118160628579, 118160628580, 118160628581, 118160628583, 118160628564, 118160628565, 118160628566, 118160628567, 118160628571, 118160628572, 118160628573, 118160628582, 118160628574, 118160628575, 118160628576, 118340001391, 118340001392, 118340001393, 118340001394, 118340001395, 118340001396, 118340001397, 118340001388, 118340001389, 118340001390, 119110000129, 119110000130, 119110000132, 119110000133, 119110000134, 119110000135, 119110000136, 119110000137, 119130001327, 119130001328, 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117430591640, 117430591980, 117430591981, 117490599622, 117490599623, 117490599624, 117490599625, 117490599627, 117490599628, 117490599630, 117490599619, 117490599620, 117490599621, 117490599626, 117490599629, 117490599631, 117490599632, 117490599633, 117510602851, 117510602852, 117510602853, 117510602854, 117520603151, 117520603152, 117520603153, 117520603154, 118030606983, 118030606984, 118030606985, 118030606986, 118030606987, 118030606988, 118030606989, 118030606990, 118030606991, 118030606992, 118050609193, 118050609194, 118050609195, 118050609196, 118050609199, 118050609200, 118050609201, 118050609202, 118060611433, 118060611429, 118060611430, 118060611431, 118060611432, 118060611434, 118060611435, 118060611437, 118060611440, 118080615016, 118080615015, 118080615014, 118080615012, 118080615010, 118080615009, 118080615008, 118080615007, 118080615006, 118080615005, 118080615004, 118080615003, 118060611448, 118060611446, 118060611445, 118060611444, 118060611443, 118060611442, 118060611441, 41000-030-60, 118180634941, 118180634942, 118340001398, 118340001399, 118340001400, 118340001401, 118340001402, 118340001403, 118340001404, 118340001405, 118340001406, 118340001407, 118340001408, 118340001409, 118340001410, 118340001411, 118340001412, 120180001027, 120180001028, 120180001029, 120180001030, 120180001031, 10081765502005100, 121040002235, 121040002236, 121040002237, 121040002238, 121040002239, 121040002240, 121040002241, 121040002242, 121040002243, 121040002244, 121050001674, 121050001675, 121050001676, 121050001677, 121050001678, 121050001679, 121050001680, 121050001681, 121050001682, 121050001683, 121080000925, 121080000926, 121080000927, 122200001932, 10081765502005100, 123390000815, 123390000816, 123390000817, 123390000818, 123400000181, 123400000182, 123400000183, 123400000184, 123420000969, 123420000970, 123420000971, 123420000972, 123430002087, 123440000214, 123440000215, 123440000216, 123440000217, 123450001456, 123450001457, 123450001458, 123450001459, 123480000269, 123480000270, 123480000271, 123480000272;  f) 41000-030-62, UDI/DI 00817655020068, Serial Numbers:  118160628584, 118160628585, 118320000033, 118330000323, 118330000325, 118320000032, 118330000324, 118330000326, 118330000320, 118330000321, 118330000322, 118450000081, 118450000082, 118330000319, 118470000102, 118470000406, 118470000407, 118470000408, 118480000446, 118480000447, 118480000448, 118480000449, 118500001826, 118500001827, 118500001834, 118500001835, 118500001828, 118500001830, 118500001829, 118500001831, 118500001832, 119190000641, 119190000642, 119190000638, 119190000639, 119190000640, 118500001825, 118500001833, 119250001407, 119320001005, 119320001006, 119320001007, 119320001002, 119320001003, 119320001004, 119350002522, 119350002523, 119350002524, 119350002525, 119430001320, 119430001321, 119430001322, 119430001323, 119430001318, 119430001319, 119470002142, 119470002144, 119470002146, 119470002143, 119470002145, 119470002147, 120040000343, 120040000344, 120050001743, 120050001744, 120050001745, 120080000456, 120080000457, 120080000458, 120080000459, 120080000460, 120080000461, 120080000462, 120080000463, 120080000464, 120080000465, 120080000466, 120080000467, 120080000468, 120080000469, 120080000470, 120080000471, 120080000472, 120080000473, 120080000474, 120330000674, 120330000676, 120050001744, 120050001745, 120330000671, 120330000672, 120330000673, 120330000675, 120330000677, 120330000678, 120330000679, 120330000680, 120050001743, 120480000397, 120480000396, 120520000680, 120520000681, 120520000682, 121060001019, 121060001020, 121060001021, 121080000928, 121080000929, 121130001120, 121130001121, 121130001122, 121170000326, 121170000327, 121170000328, 121210002563, 121210002564, 121210002565, 121250000663, 121250000664, 121250000665, 121300001889, 121300001890, 121300001891, 121340000858, 121340000859, 121340000860, 121420001162, 121420001163, 121420001164, 121420001165, 121470000236, 121470000237, 121470000238, 121510001415, 121510001416, 121510001417, 122050001914, 122050001915, 122050001916, 122080000224, 122080000225, 122080000226, 122130000547, 122130000548, 122130000549, 122240001057, 122240001061, 122240001062, 122240001058, 122240001059, 122240001060, 122240001063, 122310000395, 122310000396, 122310000397, 122320000145, 122320000146, 122320000147, 122320000881, 122320000882, 122320000883, 122380000624, 122380000625, 122380000626, 122450001792, 122450001793, 122450001794, 122480001906, 122480001909, 123020001482, 123020001483, 123070001510, 123070001513, 123070001514, 123070001515, 123100001935, 123100001936, 123070001509, 123070001511, 123070001512, 123190000747, 123190000749, 123150002638, 123190000748, 123200000231, 123150002639, 123220001435, 123220001436, 123300001463, 123300001464, 123300000098, 123300000099, 123370000075, 123370000076, 122480001907, 122480001908, 123320000988, 123300001462, 123320000989, 123320000986, 123320000987, 120050001743, 120050001744, 120050001745, 120330000674, 120330000676, 120480000396, 113400177568, 116480540898, 116530547192, 116530547193, 116530547194, 117010549589, 117010549590, 117110556514, 117110556515, 117110556516, 117130560456, 117130560457, 117130560458, 117150562750, 117150562748, 117150562749, 117180567076, 117180567077, 117190568320, 117210570063, 117210570064, 117210570065, 117260575996, 117260575997, 117260575998, 117310581180, 117310581181, 117350584629, 117350584630, 117350584631, 117350584632, 117350584633, 117400589290, 117400589291, 117400589292, 117430592542, 117430592543, 117430592544, 117490599636, 117490599637, 117490599639, 117490599634, 117490599635, 117490599638, 118070612685, 118070612687, 118070612686, 118080614439, 118080614440, 118090617067, 118090617068, 118090617071, 118090617070, 118090617069, 118160628588, 118160628587, 118160628586, 118160628589, 118160628590, 118320000034, 118320000035, 118330000327, 118330000328, 118330000329, 120040000345, 120040000346, 120040000347, 120480000398, 120480000399, 120480000400, 120480000401, 120480000402, 120480000403, 120480000404, 120480000405, 120480000406, 120480000407, 120480000408, 123400000068, 123400000069;  g) 41000-030-64, UDI/DI 00817655021423, Serial Numbers:  119490000440, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 118380003022, 118380003023, 118470000103, 118470000104, 119500001336, 118380003022, 118380003023, 118470000103, 118470000104, 120070000731, 123150002068, 123150002069, 123150002070, 123160000556, 123150002055, 123200001669, 123150002057, 123150002058, 123200001670, 123200001671, 123150002066, 123150002067, 120070000733, 123150002056, 123150002061, 123150002062, 123150002063, 123150002064, 123150002065, 123150002059, 123150002060, 123160000552, 123160000553, 123160000554, 123160000555, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 117320582006, 120070000734, 120070000735, 120070000736, 120070000737, 11847000104, 120070000738, 120070000739, 121350001044, 121350001045.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}