Z-1599-2024.jsonld
type: Dataset
name: ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
description: FDA recall Z-1599-2024 — Siemens Medical Solutions USA, Inc. is recalling ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C (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/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
  manufacturer: Siemens Medical Solutions USA, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1599-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1599-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1599-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Siemens Medical Solutions USA, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-02-23
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357. Serial Numbers: 571063 556506 555717 555502 555450 555448 552655 552659 550763 556982 556990 556996 556998 557000 557001 557002 557003 555641 555631 553876 553877 556233 557117 557122 557123 556083 556082 556080 556081 556043 556044 556045 556046 556047 555714 555285 555281 555282 555283 555286 555287 555288 555290 555289 555284 550462 550460 550461 550915 550878 573362 573314 570015 573313 573132 570258 570332 575056 570033 556390 556738 556734 556545 555666 555746 552723 553173 552986 553174 550198 550541 550310 550214 550052 550051 573202 575041 571545 570335 570288 570227 575050 575051 556510 575011 570057 570058 570028 556973 557069 556967 556974 556920 555875 556598 556514 556399 556004 555693 555107 555719 555545 555477 555429 555197 555167 555215 555144 555124 555155 553043 553161 552998 553829 553542 553435 555033 553437 553438 553302 552775 551895 551967 551970 550940 555364 555368 555622 555966 556295 556334 556462 556463 556464 556490 556724 556727 556735 556812 556885 557057 557063 557068 557127 557306 557393 570031 570118 570196 571568 573178 573343 573439 576207 576231 576245 578060 557401 557372 555951 573052 555729 557113 556508 556052 555514 555530 555166 570067 573422 578089 573392 573393 570174 573044 570066 556783 556784 556650 555611 556358 556008 556030 555109 555985 555100 555121 555793 555701 555625 555544 555390 555202 555171 552907 553037 552729 553468 552594 552937 551775 550993 550834 550294 550038 556557 556271 555967 555607 555311 552708 551574 550029 557114 557252 557364 557370 555671 550775 570349 557300 570379 570357 570364 570373 570381 557299 572027 576011 576012 570384 570351 570359 570367 570368 570387 570389 570358 570391 570352 570366 570378 570386 570388 570390 570218 570338 570353 570365 570377 570382 570383 570348 570354 570355 570356 570362 570363 570371 570372 570374 570375 570380 556997 557294 570350 570341 557292 557293 557014 557015 557239 557240 557238 …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1599-2024: Siemens Medical Solutions USA, Inc. is recalling ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
text: The FDA logged enforcement record Z-1599-2024: Siemens Medical Solutions USA, Inc. is voluntarily recalling ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C — reason: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-23. Affected lots/codes: REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357. Serial Numbers: 571063 556506 555717 555502 555450 555448 552655 552659 550763 556982 556990 556996 556998 557000 557001 557002 557003 555641 555631 553876 553877 556233 557117 557122 557123 556083 556082 556080 556081 556043 556044 556045 556046 556047 555714 555285 555281 555282 555283 555286 555287 555288 555290 555289 555284 550462 550460 550461 550915 550878 573362 573314 570015 573313 573132 570258 570332 575056 570033 556390 556738 556734 556545 555666 555746 552723 553173 552986 553174 550198 550541 550310 550214 550052 550051 573202 575041 571545 570335 570288 570227 575050 575051 556510 575011 570057 570058 570028 556973 557069 556967 556974 556920 555875 556598 556514 556399 556004 555693 555107 555719 555545 555477 555429 555197 555167 555215 555144 555124 555155 553043 553161 552998 553829 553542 553435 555033 553437 553438 553302 552775 551895 551967 551970 550940 555364 555368 555622 555966 556295 556334 556462 556463 556464 556490 556724 556727 556735 556812 556885 557057 557063 557068 557127 557306 557393 570031 570118 570196 571568 5731…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-1599-2024 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.