MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
type: Dataset
description: FDA recall Z-1938-2025 — GE Medical Systems Information Technologies Inc is recalling MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. (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: MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
  type: MedicalDevice
  manufacturer: GE Medical Systems Information Technologies Inc
claims: enforcement-record
claims: FDA classified recall Z-1938-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1938-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1938-2025
      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: GE Medical Systems Information Technologies Inc
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-04-25
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Serial Numbers: ABF04400266FA SAD04390481GA SAD05091885GA SAD05091907GA SAD05091908GA PA2155054 PA2155057 PA2155059 PA2155061 PA2155063 SAD05302639GA SAD05302646GA SAD05322687GA SAD05322723GA SAD05322735GA SAD06524784GA SAD06204075GA SAD06204076GA SAD06204077GA SAD04380416GA SAD04380427GA SAD04430607GA SAD04440716GA SAD04440717GA SAD04440718GA SAD04440719GA SAD05453127GA SAD05453128GA SAD05453129GA SAD05453130GA SAD05453172GA SAD08105319GA SAD08105320GA SAD04501236GA SAD04501237GA SAD04501252GA SAD04501257GA SAD04501258GA SAD04350305GA SAD04350317GA SAD04350318GA SAD04350319GA SAD04350320GA SAD04350326GA SAD06424592GA SAD06444630GA SAD06454662GA SAD04491128GA SAD04491129GA SAD04491130GA SAD04491131GA SAD04491132GA SAD04491151GA SAD04501216GA SAD04501217GA SAD04501218GA SAD04501220GA SAD04501221GA SAD04501222GA SAD04501223GA SAD04501224GA SAD04501225GA SAD04501226GA SAD04501227GA SAD04501228GA SAD04501229GA PA2020935 PA2020936 SAD05081763GA SAD05081836GA SAD05091867GA SAD05091868GA SAD0932 SAD09335621GA SAD09335622GA SAD05302635GA SAD06344526GA SAD05091896GA SAD05091905GA SAD05091906GA SAD06424610GA SAD06444638GA SAD06194039GA SAD06194040GA SAD06194041GA SAD05172239GA SAD05172240GA SAD05172241GA SAD05172242GA SAD05172243GA SAD05172268GA SAD05172269GA SAD05172271GA SAD06204073GA SAD05382932GA SAD05392967GA SAD07455199GA SAD08285434GA SAD06113777GA SAD06113778GA SAD06113779GA SAD06113780GA PA2297273 SAD07205030GA SAD07205031GA SAD07215068GA SAD07215069GA SAD05302649GA SAD05322725GA SAD05332753GA SAD05352769GA SAD05473247GA SAD06023533GA SAD06023574GA SAD06474699GA SAD05513429GA SAD05513433GA SAD05513435GA SAD05513436GA SAD05523459GA SAD08355476GA SAD05021340GA SAD05021369GA SAD05021370GA SAD05021371GA SAD05352768GA SAD05352770GA SAD05352776GA SAD05352777GA SAD05503390GA SAD05503394GA SAD05503395GA SAD05523447GA SAD05523448GA SAD05523449GA SAD06033597GA SAD06033598GA SAD06033599GA SAD06033600GA SAD06033601GA SAD04491155GA SAD04491156GA SAD04491157GA SAD06444629GA SAD064…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1938-2025: GE Medical Systems Information Technologies Inc is recalling MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
text: The FDA logged enforcement record Z-1938-2025: GE Medical Systems Information Technologies Inc is voluntarily recalling MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. — reason: The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-25. Affected lots/codes: Serial Numbers: ABF04400266FA SAD04390481GA SAD05091885GA SAD05091907GA SAD05091908GA PA2155054 PA2155057 PA2155059 PA2155061 PA2155063 SAD05302639GA SAD05302646GA SAD05322687GA SAD05322723GA SAD05322735GA SAD06524784GA SAD06204075GA SAD06204076GA SAD06204077GA SAD04380416GA SAD04380427GA SAD04430607GA SAD04440716GA SAD04440717GA SAD04440718GA SAD04440719GA SAD05453127GA SAD05453128GA SAD05453129GA SAD05453130GA SAD05453172GA SAD08105319GA SAD08105320GA SAD04501236GA SAD04501237GA SAD04501252GA SAD04501257GA SAD04501258GA SAD04350305GA SAD04350317GA SAD04350318GA SAD04350319GA SAD04350320GA SAD04350326GA SAD06424592GA SAD06444630GA SAD06454662GA SAD04491128GA SAD04491129GA SAD04491130GA SAD04491131GA SAD04491132GA SAD04491151GA SAD04501216GA SAD04501217GA SAD04501218GA SAD04501220GA SAD04501221GA SAD04501222GA SAD04501223GA SAD04501224GA SAD04501225GA SAD04501226GA SAD04501227GA SAD04501228GA SAD04501229GA PA2020935 PA2020936 SAD05081763GA SAD05081836GA SAD05091867GA SAD05091868GA SAD0932 SAD09335621GA SAD09335622GA SAD05302635GA SAD06344526GA SAD05091896GA SAD05091905GA SAD05091906GA SAD06424610GA SAD06444638GA SAD06194039GA SAD06194040GA SAD06194041GA SAD05172239GA SAD05172240GA SAD05172241GA SAD05172242GA SAD05172243GA SAD05172268GA SAD05172269GA SAD05172271GA SAD06204073GA SAD05382932GA SAD05392967GA SAD07455199GA SAD08285434GA SAD06113777GA SAD061137…
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-1938-2025 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.