{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "CARESCAPE Canvas Smart Display,   Model Numbers:   a)\t5514418,  b)\t5514418 / MAEP2,  c)\t5514418-01059642,  d)\t5514418-01080402,  e)\t5514418-01081317,  f)\t5514418-01086007,  g)\t5514418-01086838,  h)\t5514418-01088182,  i)\t5514418-01108442,  j)\t5514418-01118673,  k)\t5514418-01120764,  l)\t5514418-01166521,  m)\t5514418-01180241,  n)\t5514418-01181177,  o)\t5514418-01183037,  p)\t5514418-01184556,  q)\t5514418-01184557,  r)\t5514418-01185805,  s)\t5514418-01186277,  t)\t5514418-01187473,  u)\t5514418-01188453,  v)\t5514418-01190677,  w)\t5514418-01192703,  x)\t5514418-01192705,  y)\t5514418-01203242,  z)\t5514418-01206279,  aa)\t5514418-01208248,  bb)\t5514418-01212670,  cc)\t5514418-01215947,  dd)\t5514418-01218564,  ee)\t5514418-01222489,  ff)\t5514418-01222812,  gg)\t5514418-01223831,  hh)\tii)\t5514418-01228038,  ii)\t5514418-01228181,  jj)\t5514418-01230534,  kk)\t5514418-01235322,  ll)\t5514418-01236388,  mm)\t5514418-01244357,  nn)\t5514418-01250690,  oo)\t5514418-01250761,  pp)\t5514418-01256439;  monitor, physiological, patient",
  "description": "FDA recall Z-2170-2024 — GE Healthcare Finland Oy is recalling CARESCAPE Canvas Smart Display,   Model Numbers:   a)\t5514418,  b)\t5514418 / MAEP2,  c)\t5514418-01059642,  d)\t5514418-01080402,  e)\t5514418-01081317,  f)\t5514418-01086007,  g)\t5514418-01086838,  h)\t5514418-01088182,  i)\t5514418-01108442,  j)\t5514418-01118673,  k)\t5514418-01120764,  l)\t5514418-01166521,  m)\t5514418-01180241,  n)\t5514418-01181177,  o)\t5514418-01183037,  p)\t5514418-01184556,  q)\t5514418-01184557,  r)\t5514418-01185805,  s)\t5514418-01186277,  t)\t5514418-01187473,  u)\t5514418-01188453,  v)\t5514418-01190677,  w)\t5514418-01192703,  x)\t5514418-01192705,  y)\t5514418-01203242,  z)\t5514418-01206279,  aa)\t5514418-01208248,  bb)\t5514418-01212670,  cc)\t5514418-01215947,  dd)\t5514418-01218564,  ee)\t5514418-01222489,  ff)\t5514418-01222812,  gg)\t5514418-01223831,  hh)\tii)\t5514418-01228038,  ii)\t5514418-01228181,  jj)\t5514418-01230534,  kk)\t5514418-01235322,  ll)\t5514418-01236388,  mm)\t5514418-01244357,  nn)\t5514418-01250690,  oo)\t5514418-01250761,  pp)\t5514418-01256439;  monitor, physiological, patient (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": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "CARESCAPE Canvas Smart Display,   Model Numbers:   a)\t5514418,  b)\t5514418 / MAEP2,  c)\t5514418-01059642,  d)\t5514418-01080402,  e)\t5514418-01081317,  f)\t5514418-01086007,  g)\t5514418-01086838,  h)\t5514418-01088182,  i)\t5514418-01108442,  j)\t5514418-01118673,  k)\t5514418-01120764,  l)\t5514418-01166521,  m)\t5514418-01180241,  n)\t5514418-01181177,  o)\t5514418-01183037,  p)\t5514418-01184556,  q)\t5514418-01184557,  r)\t5514418-01185805,  s)\t5514418-01186277,  t)\t5514418-01187473,  u)\t5514418-01188453,  v)\t5514418-01190677,  w)\t5514418-01192703,  x)\t5514418-01192705,  y)\t5514418-01203242,  z)\t5514418-01206279,  aa)\t5514418-01208248,  bb)\t5514418-01212670,  cc)\t5514418-01215947,  dd)\t5514418-01218564,  ee)\t5514418-01222489,  ff)\t5514418-01222812,  gg)\t5514418-01223831,  hh)\tii)\t5514418-01228038,  ii)\t5514418-01228181,  jj)\t5514418-01230534,  kk)\t5514418-01235322,  ll)\t5514418-01236388,  mm)\t5514418-01244357,  nn)\t5514418-01250690,  oo)\t5514418-01250761,  pp)\t5514418-01256439;  monitor, physiological, patient",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "GE Healthcare Finland Oy"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2170-2024: GE Healthcare Finland Oy is recalling CARESCAPE Canvas Smart Display,   Model Numbers:   a)\t5514418,  b)\t5514418 / MAEP2,  c)\t5514418-01059642,  d)\t5514418-01080402,  e)\t5514418-01081317,  f)\t5514418-01086007,  g)\t5514418-01086838,  h)\t5514418-01088182,  i)\t5514418-01108442,  j)\t5514418-01118673,  k)\t5514418-01120764,  l)\t5514418-01166521,  m)\t5514418-01180241,  n)\t5514418-01181177,  o)\t5514418-01183037,  p)\t5514418-01184556,  q)\t5514418-01184557,  r)\t5514418-01185805,  s)\t5514418-01186277,  t)\t5514418-01187473,  u)\t5514418-01188453,  v)\t5514418-01190677,  w)\t5514418-01192703,  x)\t5514418-01192705,  y)\t5514418-01203242,  z)\t5514418-01206279,  aa)\t5514418-01208248,  bb)\t5514418-01212670,  cc)\t5514418-01215947,  dd)\t5514418-01218564,  ee)\t5514418-01222489,  ff)\t5514418-01222812,  gg)\t5514418-01223831,  hh)\tii)\t5514418-01228038,  ii)\t5514418-01228181,  jj)\t5514418-01230534,  kk)\t5514418-01235322,  ll)\t5514418-01236388,  mm)\t5514418-01244357,  nn)\t5514418-01250690,  oo)\t5514418-01250761,  pp)\t5514418-01256439;  monitor, physiological, patient",
      "text": "The FDA logged enforcement record Z-2170-2024: GE Healthcare Finland Oy is voluntarily recalling CARESCAPE Canvas Smart Display,   Model Numbers:   a)\t5514418,  b)\t5514418 / MAEP2,  c)\t5514418-01059642,  d)\t5514418-01080402,  e)\t5514418-01081317,  f)\t5514418-01086007,  g)\t5514418-01086838,  h)\t5514418-01088182,  i)\t5514418-01108442,  j)\t5514418-01118673,  k)\t5514418-01120764,  l)\t5514418-01166521,  m)\t5514418-01180241,  n)\t5514418-01181177,  o)\t5514418-01183037,  p)\t5514418-01184556,  q)\t5514418-01184557,  r)\t5514418-01185805,  s)\t5514418-01186277,  t)\t5514418-01187473,  u)\t5514418-01188453,  v)\t5514418-01190677,  w)\t5514418-01192703,  x)\t5514418-01192705,  y)\t5514418-01203242,  z)\t5514418-01206279,  aa)\t5514418-01208248,  bb)\t5514418-01212670,  cc)\t5514418-01215947,  dd)\t5514418-01218564,  ee)\t5514418-01222489,  ff)\t5514418-01222812,  gg)\t5514418-01223831,  hh)\tii)\t5514418-01228038,  ii)\t5514418-01228181,  jj)\t5514418-01230534,  kk)\t5514418-01235322,  ll)\t5514418-01236388,  mm)\t5514418-01244357,  nn)\t5514418-01250690,  oo)\t5514418-01250761,  pp)\t5514418-01256439;  monitor, physiological, patient — reason: GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-05. Affected lots/codes: GTIN 00195278522313: a) 5514418, Serial Numbers:  STZ22221001HA, STZ22230001HA, STZ22230002HA, STZ22230003HA, STZ22230004HA, STZ22230006HA, STZ22230007HA, STZ22230008HA, STZ22230009HA, STZ22230010HA, STZ22230011HA, STZ22230013HA, STZ22230014HA, STZ22230017HA, STZ22230018BP, STZ22230019HA, STZ22230020HA, STZ22230021HA, STZ22230022BP, STZ22230023HA, STZ22230024HA, STZ22230028HA, STZ22230029HA, STZ23140013HX, STZ23270003SA, STZ23360005SA, STZ23360008SA, STZ24020008SA, STZ24020009SA, STZ24020012SA;   b) 5514418 / MAEP2, Serial Numbers:  SU221320001HP, SU221320002HP, SU221320003HP, SU221320004HP, SU221320005HP, SU221320006HP, SU221320007HP, SU221320008HP, SU221320009HP, SU221320010HP, SU221320011HP, SU221320012HP, SU221320013HP, SU221320014HP, SU221320015HP, SU221320016HP, SU221320017HP, SU221320018HP, SU221320019HP, SU221320020HP, SU221320021HP, SU221320022HP, SU221320023HP, SU221320024HP, SU221320025HP, SU221320026HP, SU221320027HP, SU221320028HP, SU221320029HP, SU221320030HP, SU221320031HP, SU221320032HP, SU221320033HP, SU221320034HP, SU221320035HP, SU221320036HP, SU221320037HP, SU221320038HP, SU221320039HP, SU221320040HP;   c) 5514418-01059642, Serial Numbers:  STZ22230012HA, STZ22230015HA;   d) 5514418-01080402, Serial Numbers:  STZ22320001HA;   e) 5514418-01081317, Serial Numbers:  STZ22320009HA, STZ22320010HA, STZ22320011HA, STZ22320012HA, STZ22320013HA, STZ22320014HA;   f) 5514418-01086007, Serial Numbers:  STZ22230027HA;   g) 5514418-01086838, Serial Numbers:  STZ22320003HA, STZ22320004HA, STZ23310112HA, STZ23310113HA, STZ23310114HA, STZ23310123HA, STZ23310125HA, STZ23310126HA, STZ23310130HA, STZ23320158HA, STZ23320159HA, STZ23320160HA, STZ23320161HA, STZ23320162HA;   h) 5514418-01088182, Serial Numbers:  STZ22320006HA, STZ22320007HA;   i) 5514418-01108442, Serial Numbers:  STZ22220001HA, STZ22230016HA, STZ22230025HA, STZ22230026HA, STZ22320002HA, STZ22320005HA, STZ22320008HA, STZ22320015HA, STZ22320016HA, STZ22320017HA, STZ22320018HA, STZ22320019HA, STZ22320020HA, STZ22320021HA, STZ22320022HA, STZ22320023HA, STZ22320024HA, STZ22320025HA, STZ22320026HA, STZ22320028HA, STZ22320029HA;   j) 5514418-01118673, Serial Numbers:  STZ23120002HA, STZ23120003HA, STZ23120004HA, STZ23120005HA, STZ23120006HA, STZ23120007HA, STZ23120008HA, STZ23120009HA, STZ23120010HA, STZ23120011HA, STZ23120012HA;   k) 5514418-01120764, Serial Numbers:  STZ22320027HA;   l) 5514418-01166521, Serial Numbers:  STZ23190001HA, STZ23190002HA, STZ23190003HA, STZ23190004HA, STZ23190005HA, STZ23190006HA, STZ23190007HA, STZ23220001HA, STZ23220002HA, STZ23240012HA;   m) 5514418-01180241, Serial Numbers:  STZ23290053HA, STZ23290060HA, STZ23310067HA, STZ23310068HA, STZ23310070HA, STZ23310073HA, STZ23310075HA, STZ23310077HA, STZ23310078HA, STZ23310080HA, STZ23310081HA, STZ23310082HA, STZ23310084HA, STZ23310085HA, STZ23310086HA, STZ23310087HA, STZ23310088HA, STZ23310089HA, STZ23310091HA, STZ23310092HA, STZ23310094HA, STZ23310095HA, STZ23310096HA, STZ23310097HA, STZ23310099HA, STZ23310100HA, STZ23310102HA, STZ23310103HA, STZ23310104HA, STZ23310105HA, STZ23310106HA, STZ23310107HA, STZ23310108HA, STZ23310109HA, STZ23310111HA, STZ23310121HA, STZ23310127HA, STZ23310128HA, STZ23310129HA, STZ23310131HA, STZ23310134HA, STZ23310135HA, STZ23310136HA, STZ23310137HA, STZ23310139HA, STZ23310140HA, STZ23310142HA, STZ23310143HA, STZ23310144HA, STZ23320145HA, STZ23320146HA, STZ23320147HA, STZ23320150HA, STZ23320153HA, STZ23320154HA, STZ23320155HA, STZ23320156HA, STZ23320163HA, STZ23320164HA, STZ23320166HA, STZ23320167HA, STZ23320168HA, STZ23340200HA, STZ23340201HA, STZ23340202HA, STZ23340203HA, STZ23340204HA, STZ23380031HA, STZ23380032HA, STZ23380033HA, STZ23380034HA, STZ23380035HA, STZ23380036HA, STZ23380038HA, STZ23380039HA, STZ23380040HA, STZ23380041HA, STZ23380042HA, STZ23380044HA, STZ23380045HA, STZ23380046HA, STZ23380047HA;   n) 5514418-01181177, Serial Numbers:  STZ23240001HA, STZ23240007HA, STZ23240008HA, STZ23240002HA, STZ23240003HA, STZ23240004HA, STZ23240005HA, STZ23240006HA, STZ23240014HA, STZ23240015HA, STZ23240016HA, STZ23240017HA, STZ23240018HA, STZ23240019HA, STZ23240020HA, STZ23240021HA, STZ23240022HA, STZ23240023HA, STZ23240024HA, STZ23240026HA, STZ23240027HA;   o) 5514418-01183037, Serial Numbers:  STZ23240009HA, STZ23240010HA, STZ23240011HA, STZ23240013HA;   p) 5514418-01184556, Serial Numbers:  STZ23310071HA, STZ23310122HA, STZ23310132HA, STZ23310133HA, STZ23310138HA, STZ23310141HA, STZ23340187HA, STZ23340188HA, STZ23340189HA, STZ23340190HA, STZ23340191HA, STZ23340192HA, STZ23340195HA, STZ23340196HA, STZ23340197HA, STZ23340198HA, STZ23340217HA, STZ23340218HA, STZ23340219HA, STZ23340220HA, STZ23340221HA, STZ23340222HA;   q) 5514418-01184557, Serial Numbers:  STZ23310093HA, STZ23310098HA, STZ23310101HA, STZ23310110HA, STZ23310124HA;   r) 5514418-01185805, Serial Numbers:  STZ23290031HA, STZ23290032HA, STZ23290033HA, STZ23290034HA, STZ23290035HA, STZ23290036HA, STZ23290037HA, STZ23290038HA, STZ23290039HA, STZ23290040HA, STZ23290041HA, STZ23290042HA, STZ23290043HA, STZ23290044HA, STZ23290045HA, STZ23290046HA, STZ23290047HA, STZ23290048HA, STZ23290050HA, STZ23290051HA, STZ23290052HA, STZ23290055HA, STZ23290056HA, STZ23290057HA, STZ23290058HA, STZ23290059HA, STZ23290061HA, STZ23290062HA, STZ23290063HA, STZ23290064HA, STZ23290065HA, STZ23290066HA;    s) 5514418-01186277, Serial Numbers:  STZ23340179HA, STZ23340180HA, STZ23340181HA, STZ23340182HA, STZ23340183HA, STZ23340184HA, STZ23340185HA, STZ23340186HA, STZ23340211HA, STZ23340212HA, STZ23340213HA, STZ23340214HA, STZ23340215HA, STZ23340216HA;   t) 5514418-01187473, Serial Numbers:  STZ23310069HA, STZ23310072HA, STZ23310074HA, STZ23310076HA, STZ23310079HA, STZ23310083HA, STZ23310090HA, STZ23320148HA, STZ23320149HA, STZ23320151HA, STZ23320157HA, STZ23320165HA, STZ23320169HA, STZ23320170HA, STZ23320171HA, STZ23320172HA, STZ23320173HA, STZ24020007SA;   u) 5514418-01188453, Serial Numbers:  STZ23240025HA, STZ23320152HA;   v) 5514418-01190677, Serial Numbers:  STZ23290049HA, STZ23290054HA, STZ23390041HA, STZ23400006HA;   w) 5514418-01192703, Serial Numbers:  STZ23360015SA;   x) 5514418-01192705, Serial Numbers:  STZ23360013SA;   y) 5514418-01203242, Serial Numbers:  STZ23390030HA, STZ23390037HA, STZ23390038HA, STZ23390039HA, STZ23400001HA, STZ23400002HA, STZ23400003HA, STZ23400004HA, STZ23400005HA;   z) 5514418-01206279, Serial Numbers:  STZ23390016HA, STZ23360006SA, STZ23360010SA, STZ23360011SA, STZ23360012SA, STZ23360014SA, STZ23360016SA, STZ23360019SA, STZ23500002SA, STZ23510001SA, STZ23510002SA, STZ23510003SA, STZ23510004SA, STZ23510005SA, STZ23510006SA, STZ23510007SA, STZ23510008SA, STZ23510009SA, STZ23510010SA, STZ23510011SA, STZ23510012SA, STZ23510013SA, STZ23510020SA, STZ23510022SA, STZ23510024SA, STZ23510025SA, STZ23510026SA, STZ23510027SA, STZ23510028SA, STZ23510029SA, STZ23510030SA, STZ23510035SA, STZ23510036SA, STZ23510038SA, STZ23510039SA, STZ23510041SA, STZ23340193HA, STZ23340227HA, STZ23340228HA;   aa) 5514418-01208248, Serial Numbers:  STZ23340175HA, STZ23340176HA, STZ23340177HA, STZ23340178HA, STZ23340194HA, STZ23340205HA, STZ23340206HA, STZ23340207HA, STZ23340208HA, STZ23340209HA, STZ23340210HA;   bb) 5514418-01212670, Serial Numbers:  STZ23340223HA, STZ23340224HA, STZ23340225HA, STZ23340226HA;   cc) 5514418-01215947, Serial Numbers:  STZ23380001HA, STZ23380002HA, STZ23380003HA, STZ23380004HA, STZ23380005HA, STZ23380006HA, STZ23380007HA, STZ23380008HA, STZ23380009HA, STZ23380010HA, STZ23380011HA, STZ23380012HA, STZ23380013HA, STZ23380014HA, STZ23380015HA, STZ23380016HA, STZ23380017HA, STZ23380018HA, STZ23380019HA, STZ23380020HA, STZ23380021HA, STZ23380022HA, STZ23380023HA, STZ23380024HA, STZ23380025HA, STZ23380026HA, STZ23380027HA, STZ23380028HA, STZ23380029HA, STZ23380030HA, STZ23380049HA, STZ23380050HA, STZ23380051HA, STZ23380052HA, STZ23380053HA, STZ23380054HA, STZ23360007SA, STZ23360009SA, STZ23360017SA, STZ23360018SA, STZ23510014SA, STZ23510015SA, STZ23510016SA, STZ23510017SA, STZ23510018SA, STZ23510019SA, STZ23510021SA, STZ23510023SA, STZ23510031SA, STZ23510032SA, STZ23510033SA, STZ23510034SA, STZ23510037SA, STZ23510040SA, STZ24020026SA, STZ24020028SA, STZ24020033SA, STZ24020034SA, STZ24020035SA, STZ24020037SA, STZ24020039SA, STZ24020041SA, STZ24020042SA, STZ24040001SA, STZ24040002SA, STZ24040003SA, STZ24040004SA, STZ24040007SA;   dd) 5514418-01218564, Serial Numbers:  STZ23380037HA, STZ23380048HA;   ee) 5514418-01222489, Serial Numbers:  STZ23390013HA, STZ23390014HA, STZ23390015HA, STZ23390020HA, STZ23390021HA, STZ23390040HA;   ff) 5514418-01222812, Serial Numbers:  STZ23390031HA, STZ23390032HA, STZ23390036HA, STZ23390042HA;   gg) 5514418-01223831, Serial Numbers:  STZ23340199HA, STZ23380043HA, STZ23380055HA, STZ23380056HA, STZ23380057HA, STZ23390001HA, STZ23390002HA, STZ23390003HA, STZ23390004HA, STZ23390005HA, STZ23390006HA, STZ23390007HA, STZ23390008HA, STZ23390009HA, STZ23390010HA, STZ23390011HA, STZ23390012HA;   hh) ii) 5514418-01228038, Serial Numbers:  STZ23380058HA, STZ23380059HA, STZ23380060HA, STZ23390025HA, STZ23390026HA, STZ23390027HA, STZ23390028HA, STZ23390029HA, STZ23390033HA, STZ23390034HA, STZ23390035HA;   ii) 5514418-01228181, Serial Numbers:  STZ24040024SA;   jj) 5514418-01230534, Serial Numbers:  STZ24020006SA;   kk) 5514418-01235322, Serial Numbers:  STZ23390017HA;   ll) 5514418-01236388, Serial Numbers:  STZ23390018HA, STZ23390019HA, STZ23410001HA  mm) 5514418-01244357, Serial Numbers:  STZ23490001SA, STZ23490002SA;   nn) 5514418-01250690, Serial Numbers:  STZ24020004HA, STZ24020005HA, STZ24040001HA, STZ24040002HA, STZ24040003HA, STZ24040004HA, STZ24040005HA, STZ24040006HA, STZ24050002HA, STZ24050003HA, STZ24050004HA, STZ24050005HA, STZ24050006HA;   oo) 5514418-01250761, Serial Numbers:  STZ24010001SA, STZ24010002SA, STZ24010003SA, STZ24010004SA, STZ24010008SA, STZ24010009SA, STZ24010010SA, STZ24010011SA;   pp) 5514418-01256439, Serial Numbers:  STZ23390022HA, STZ24020006HA. 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-2170-2024&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-2170-2024&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-2170-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2170-2024 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-2170-2024&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-2170-2024&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-2170-2024/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-2170-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2170-2024",
            "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": "GE Healthcare Finland Oy",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-05",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00195278522313: a) 5514418, Serial Numbers:  STZ22221001HA, STZ22230001HA, STZ22230002HA, STZ22230003HA, STZ22230004HA, STZ22230006HA, STZ22230007HA, STZ22230008HA, STZ22230009HA, STZ22230010HA, STZ22230011HA, STZ22230013HA, STZ22230014HA, STZ22230017HA, STZ22230018BP, STZ22230019HA, STZ22230020HA, STZ22230021HA, STZ22230022BP, STZ22230023HA, STZ22230024HA, STZ22230028HA, STZ22230029HA, STZ23140013HX, STZ23270003SA, STZ23360005SA, STZ23360008SA, STZ24020008SA, STZ24020009SA, STZ24020012SA;   b) 5514418 / MAEP2, Serial Numbers:  SU221320001HP, SU221320002HP, SU221320003HP, SU221320004HP, SU221320005HP, SU221320006HP, SU221320007HP, SU221320008HP, SU221320009HP, SU221320010HP, SU221320011HP, SU221320012HP, SU221320013HP, SU221320014HP, SU221320015HP, SU221320016HP, SU221320017HP, SU221320018HP, SU221320019HP, SU221320020HP, SU221320021HP, SU221320022HP, SU221320023HP, SU221320024HP, SU221320025HP, SU221320026HP, SU221320027HP, SU221320028HP, SU221320029HP, SU221320030HP, SU221320031HP, SU221320032HP, SU221320033HP, SU221320034HP, SU221320035HP, SU221320036HP, SU221320037HP, SU221320038HP, SU221320039HP, SU221320040HP;   c) 5514418-01059642, Serial Numbers:  STZ22230012HA, STZ22230015HA;   d) 5514418-01080402, Serial Numbers:  STZ22320001HA;   e) 5514418-01081317, Serial Numbers:  STZ22320009HA, STZ22320010HA, STZ22320011HA, STZ22320012HA, STZ22320013HA, STZ22320014HA;   f) 5514418-01086007, Serial Numbers:  STZ22230027HA;   g) 5514418-01086838, Serial Numbers:  STZ22320003HA, STZ22320004HA, STZ23310112HA, STZ23310113HA, STZ23310114HA, STZ23310123HA, STZ23310125HA, STZ23310126HA, STZ23310130HA, STZ23320158HA, STZ23320159HA, STZ23320160HA, STZ23320161HA, STZ23320162HA;   h) 5514418-01088182, Serial Numbers:  STZ22320006HA, STZ22320007HA;   i) 5514418-01108442, Serial Numbers:  STZ22220001HA, STZ22230016HA, STZ22230025HA, STZ22230026HA, STZ22320002HA, STZ22320005HA, STZ22320008HA, STZ22320015HA, STZ22320016HA, STZ22320017HA, STZ22320018HA, STZ22320019HA, STZ22320020HA, STZ22320021HA, STZ22320022HA, STZ22320023HA, STZ22320024HA, STZ22320025HA, STZ22320026HA, STZ22320028HA, STZ22320029HA;   j) 5514418-01118673, Serial Numbers:  STZ23120002HA, STZ23120003HA, STZ23120004HA, STZ23120005HA, STZ23120006HA, STZ23120007HA, STZ23120008HA, STZ23120009HA, STZ23120010HA, STZ23120011HA, STZ23120012HA;   k) 5514418-01120764, Serial Numbers:  STZ22320027HA;   l) 5514418-01166521, Serial Numbers:  STZ23190001HA, STZ23190002HA, STZ23190003HA, STZ23190004HA, STZ23190005HA, STZ23190006HA, STZ23190007HA, STZ23220001HA, STZ23220002HA, STZ23240012HA;   m) 5514418-01180241, Serial Numbers:  STZ23290053HA, STZ23290060HA, STZ23310067HA, STZ23310068HA, STZ23310070HA, STZ23310073HA, STZ23310075HA, STZ23310077HA, STZ23310078HA, STZ23310080HA, STZ23310081HA, STZ23310082HA, STZ23310084HA, STZ23310085HA, STZ23310086HA, STZ23310087HA, STZ23310088HA, STZ23310089HA, STZ23310091HA, STZ23310092HA, STZ23310094HA, STZ23310095HA, STZ23310096HA, STZ23310097HA, STZ23310099HA, STZ23310100HA, STZ23310102HA, STZ23310103HA, STZ23310104HA, STZ23310105HA, STZ23310106HA, STZ23310107HA, STZ23310108HA, STZ23310109HA, STZ23310111HA, STZ23310121HA, STZ23310127HA, STZ23310128HA, STZ23310129HA, STZ23310131HA, STZ23310134HA, STZ23310135HA, STZ23310136HA, STZ23310137HA, STZ23310139HA, STZ23310140HA, STZ23310142HA, STZ23310143HA, STZ23310144HA, STZ23320145HA, STZ23320146HA, STZ23320147HA, STZ23320150HA, STZ23320153HA, STZ23320154HA, STZ23320155HA, STZ23320156HA, STZ23320163HA, STZ23320164HA, STZ23320166HA, STZ23320167HA, STZ23320168HA, STZ23340200HA, STZ23340201HA, STZ23340202HA, STZ23340203HA, STZ23340204HA, STZ23380031HA, STZ23380032HA, STZ23380033HA, STZ23380034HA, STZ23380035HA, STZ23380036HA, STZ23380038HA, STZ23380039HA, STZ23380040HA, STZ23380041HA, STZ23380042HA, STZ23380044HA, STZ23380045HA, STZ23380046HA, STZ23380047HA;   n) 5514418-01181177, Serial Numbers:  STZ23240001HA, STZ23240007HA, STZ23240008HA, STZ23240002HA, STZ23240003HA, STZ23240004HA, STZ23240005HA, STZ23240006HA, STZ23240014HA, STZ23240015HA, STZ23240016HA, STZ23240017HA, STZ23240018HA, STZ23240019HA, STZ23240020HA, STZ23240021HA, STZ23240022HA, STZ23240023HA, STZ23240024HA, STZ23240026HA, STZ23240027HA;   o) 5514418-01183037, Serial Numbers:  STZ23240009HA, STZ23240010HA, STZ23240011HA, STZ23240013HA;   p) 5514418-01184556, Serial Numbers:  STZ23310071HA, STZ23310122HA, STZ23310132HA, STZ23310133HA, STZ23310138HA, STZ23310141HA, STZ23340187HA, STZ23340188HA, STZ23340189HA, STZ23340190HA, STZ23340191HA, STZ23340192HA, STZ23340195HA, STZ23340196HA, STZ23340197HA, STZ23340198HA, STZ23340217HA, STZ23340218HA, STZ23340219HA, STZ23340220HA, STZ23340221HA, STZ23340222HA;   q) 5514418-01184557, Serial Numbers:  STZ23310093HA, STZ23310098HA, STZ23310101HA, STZ23310110HA, STZ23310124HA;   r) 5514418-01185805, Serial Numbers:  STZ23290031HA, STZ23290032HA, STZ23290033HA, STZ23290034HA, STZ23290035HA, STZ23290036HA, STZ23290037HA, STZ23290038HA, STZ23290039HA, STZ23290040HA, STZ23290041HA, STZ23290042HA, STZ23290043HA, STZ23290044HA, STZ23290045HA, STZ23290046HA, STZ23290047HA, STZ23290048HA, STZ23290050HA, STZ23290051HA, STZ23290052HA, STZ23290055HA, STZ23290056HA, STZ23290057HA, STZ23290058HA, STZ23290059HA, STZ23290061HA, STZ23290062HA, STZ23290063HA, STZ23290064HA, STZ23290065HA, STZ23290066HA;    s) 5514418-01186277, Serial Numbers:  STZ23340179HA, STZ23340180HA, STZ23340181HA, STZ23340182HA, STZ23340183HA, STZ23340184HA, STZ23340185HA, STZ23340186HA, STZ23340211HA, STZ23340212HA, STZ23340213HA, STZ23340214HA, STZ23340215HA, STZ23340216HA;   t) 5514418-01187473, Serial Numbers:  STZ23310069HA, STZ23310072HA, STZ23310074HA, STZ23310076HA, STZ23310079HA, STZ23310083HA, STZ23310090HA, STZ23320148HA, STZ23320149HA, STZ23320151HA, STZ23320157HA, STZ23320165HA, STZ23320169HA, STZ23320170HA, STZ23320171HA, STZ23320172HA, STZ23320173HA, STZ24020007SA;   u) 5514418-01188453, Serial Numbers:  STZ23240025HA, STZ23320152HA;   v) 5514418-01190677, Serial Numbers:  STZ23290049HA, STZ23290054HA, STZ23390041HA, STZ23400006HA;   w) 5514418-01192703, Serial Numbers:  STZ23360015SA;   x) 5514418-01192705, Serial Numbers:  STZ23360013SA;   y) 5514418-01203242, Serial Numbers:  STZ23390030HA, STZ23390037HA, STZ23390038HA, STZ23390039HA, STZ23400001HA, STZ23400002HA, STZ23400003HA, STZ23400004HA, STZ23400005HA;   z) 5514418-01206279, Serial Numbers:  STZ23390016HA, STZ23360006SA, STZ23360010SA, STZ23360011SA, STZ23360012SA, STZ23360014SA, STZ23360016SA, STZ23360019SA, STZ23500002SA, STZ23510001SA, STZ23510002SA, STZ23510003SA, STZ23510004SA, STZ23510005SA, STZ23510006SA, STZ23510007SA, STZ23510008SA, STZ23510009SA, STZ23510010SA, STZ23510011SA, STZ23510012SA, STZ23510013SA, STZ23510020SA, STZ23510022SA, STZ23510024SA, STZ23510025SA, STZ23510026SA, STZ23510027SA, STZ23510028SA, STZ23510029SA, STZ23510030SA, STZ23510035SA, STZ23510036SA, STZ23510038SA, STZ23510039SA, STZ23510041SA, STZ23340193HA, STZ23340227HA, STZ23340228HA;   aa) 5514418-01208248, Serial Numbers:  STZ23340175HA, STZ23340176HA, STZ23340177HA, STZ23340178HA, STZ23340194HA, STZ23340205HA, STZ23340206HA, STZ23340207HA, STZ23340208HA, STZ23340209HA, STZ23340210HA;   bb) 5514418-01212670, Serial Numbers:  STZ23340223HA, STZ23340224HA, STZ23340225HA, STZ23340226HA;   cc) 5514418-01215947, Serial Numbers:  STZ23380001HA, STZ23380002HA, STZ23380003HA, STZ23380004HA, STZ23380005HA, STZ23380006HA, STZ23380007HA, STZ23380008HA, STZ23380009HA, STZ23380010HA, STZ23380011HA, STZ23380012HA, STZ23380013HA, STZ23380014HA, STZ23380015HA, STZ23380016HA, STZ23380017HA, STZ23380018HA, STZ23380019HA, STZ23380020HA, STZ23380021HA, STZ23380022HA, STZ23380023HA, STZ23380024HA, STZ23380025HA, STZ23380026HA, STZ23380027HA, STZ23380028HA, STZ23380029HA, STZ23380030HA, STZ23380049HA, STZ23380050HA, STZ23380051HA, STZ23380052HA, STZ23380053HA, STZ23380054HA, STZ23360007SA, STZ23360009SA, STZ23360017SA, STZ23360018SA, STZ23510014SA, STZ23510015SA, STZ23510016SA, STZ23510017SA, STZ23510018SA, STZ23510019SA, STZ23510021SA, STZ23510023SA, STZ23510031SA, STZ23510032SA, STZ23510033SA, STZ23510034SA, STZ23510037SA, STZ23510040SA, STZ24020026SA, STZ24020028SA, STZ24020033SA, STZ24020034SA, STZ24020035SA, STZ24020037SA, STZ24020039SA, STZ24020041SA, STZ24020042SA, STZ24040001SA, STZ24040002SA, STZ24040003SA, STZ24040004SA, STZ24040007SA;   dd) 5514418-01218564, Serial Numbers:  STZ23380037HA, STZ23380048HA;   ee) 5514418-01222489, Serial Numbers:  STZ23390013HA, STZ23390014HA, STZ23390015HA, STZ23390020HA, STZ23390021HA, STZ23390040HA;   ff) 5514418-01222812, Serial Numbers:  STZ23390031HA, STZ23390032HA, STZ23390036HA, STZ23390042HA;   gg) 5514418-01223831, Serial Numbers:  STZ23340199HA, STZ23380043HA, STZ23380055HA, STZ23380056HA, STZ23380057HA, STZ23390001HA, STZ23390002HA, STZ23390003HA, STZ23390004HA, STZ23390005HA, STZ23390006HA, STZ23390007HA, STZ23390008HA, STZ23390009HA, STZ23390010HA, STZ23390011HA, STZ23390012HA;   hh) ii) 5514418-01228038, Serial Numbers:  STZ23380058HA, STZ23380059HA, STZ23380060HA, STZ23390025HA, STZ23390026HA, STZ23390027HA, STZ23390028HA, STZ23390029HA, STZ23390033HA, STZ23390034HA, STZ23390035HA;   ii) 5514418-01228181, Serial Numbers:  STZ24040024SA;   jj) 5514418-01230534, Serial Numbers:  STZ24020006SA;   kk) 5514418-01235322, Serial Numbers:  STZ23390017HA;   ll) 5514418-01236388, Serial Numbers:  STZ23390018HA, STZ23390019HA, STZ23410001HA  mm) 5514418-01244357, Serial Numbers:  STZ23490001SA, STZ23490002SA;   nn) 5514418-01250690, Serial Numbers:  STZ24020004HA, STZ24020005HA, STZ24040001HA, STZ24040002HA, STZ24040003HA, STZ24040004HA, STZ24040005HA, STZ24040006HA, STZ24050002HA, STZ24050003HA, STZ24050004HA, STZ24050005HA, STZ24050006HA;   oo) 5514418-01250761, Serial Numbers:  STZ24010001SA, STZ24010002SA, STZ24010003SA, STZ24010004SA, STZ24010008SA, STZ24010009SA, STZ24010010SA, STZ24010011SA;   pp) 5514418-01256439, Serial Numbers:  STZ23390022HA, STZ24020006HA",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}