Z-3124-2024.jsonld
type: Dataset
name: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
description: FDA recall Z-3124-2024 — Fresenius Medical Care Holdings, Inc. is recalling Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130 (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: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
  manufacturer: Fresenius Medical Care Holdings, Inc.
claims: enforcement-record
claims: FDA classified recall Z-3124-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3124-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3124-2024
      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: Fresenius Medical Care Holdings, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-08-08
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 4T0S275804 4T0S276804 4T0S276814 4T0S276818 4T0S276829 4T0S276833 4T0S276838 4T0S276858 4T0S276867 4T0S276870 4T0S276807 4T0S276886 4T0S276894 4T0S276895 4T0S276897 4T0S276909 4T0S276911 4T0S276912 4T0S276916 4T0S276921 4T0S276926 4T0S276928 4T0S276934 4T0S276952 4T0S276960 4T0S276961 4T0S276963 4T0S276964 4T0S276965 4T0S276969 4T0S276973 4T0S276976 4T0S276979 4T0S276991 4T0S276998 4T0S276999 4T0S277004 4T0S277005 4T0S278031 4T0S278068 4T0S278087 4T0S278088 4T0S278105 4T0S278107 4T0S278109 4T0S278122 4T0S278124 4T0S278144 4T0S278149 4T0S278154 4T0S278157 4T0S278159 4T0S278183 4T0S278190 4T0S278193 4T0S278196 4T0S278198 4T0S278199 4T0S278206 4T0S278207 4T0S278217 4T0S278218 4T0S277002 4T0S277003 4T0S277025 4T0S277048 4T0S277054 4T0S277077 4T0S277090 4T0S277094 4T0S277095 4T0S277099 4T0S277115 4T0S277345 4T0S277355 4T0S277367 4T0S277371 4T0S277374 4T0S277380 4T0S277381 4T0S277392 4T0S277398 4T0S277419 4T0S277420 4T0S277424 4T0S277431 4T0S277434 4T0S277452 4T0S277459 4T0S277475 4T0S277762 …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide. Canada.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-3124-2024: Fresenius Medical Care Holdings, Inc. is recalling Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
text: The FDA logged enforcement record Z-3124-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130 — reason: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-08. Affected lots/codes: UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 4T0S275804 4T0S276804 4T0S276814 4T0S276818 4T0S276829 4T0S276833 4T0S276838 4T0S276858 4T0S276867 4T0S276870 4T0S276807 4T0S276886 4T0S276894 4T0S276895 4T0S276897 4T0S276909 4T0S276911 4T0S276912 4T0S276916 4T0S276921 4T0S276926 4T0S276928 4T0S276934 4T0S276952 4T0S276960 4T0S276961 4T0S276963 4T0S276964…
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-3124-2024 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.