Z-0454-2026.jsonld
type: Dataset
name: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
description: FDA recall Z-0454-2026 — GE Healthcare Finland Oy is recalling CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001 (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: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
  manufacturer: GE Healthcare Finland Oy
claims: enforcement-record
claims: FDA classified recall Z-0454-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0454-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0454-2026
      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 Healthcare Finland Oy
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-09-26
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI 00195278288639 Serial numbers SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV925080340SA SV925080281SA SV925080346SA SV925290119SA SV925290090SA SV925180134SA SV925160111SA SV925180131SA SV925180139SA SV925180140SA SV925180142SA SV925180143SA SV925180151SA SV925180152SA SV925160114SA SV925180141SA SV925180126SA SV925180132SA SV925180136SA SV925180135SA SV925180144SA SV925180146SA SV925180149SA SV925270007SA SV925260094SA SV925270009SA SV925270010SA SV925270008SA SV925260111SA SV925270003SA SV925270011SA SV925260085SA SV925260113SA SV925270001SA SV925270002SA SV925270006SA SV925270012SA SV925270005SA SV925270004SA SV925190002SA SV925180193SA SV925100151SA SV925100149SA SNA24400063SA SV925190009SA SV925200017SA SV925200028SA SV925190021SA SV925200022SA SV925200008SA SV925200015SA SV925200016SA SV925200021SA SV925200023SA SV925190014SA SV925200013SA SV925200012SA SV925200018SA SNA24162829SA SV925290115SA SV925220285SA SV925220291SA SV925220275SA SV925220267SA SV925220311SA SV925220240SA SV925220280SA SV925210129SA SV925220304SA SV925220255SA SV925220273SA SV925220288SA SV925210198SA SV925220281SA SV925220295SA SV925210171SA SV925220241SA SV925220290SA SV925210156SA SV925210165SA SV925210164SA SV925210163SA SV925210168SA SV925210137SA SV925210131SA SV925210141SA SV925190017SA SV925210136SA SV925210152SA SV925210162SA SV925210135SA SV925210149SA SV925210146SA SV925210126SA SV925210088SA SV925210139SA SV925150104SA SV925210158SA SV925060273SA SV925210145SA SV925210114SA SV925210166SA SV925220233SA SV925210115SA SV925210144SA SV925210153SA SV925210147SA SV925220262SA SV925220248SA SV925200025SA SV925220251SA SV925220282SA SV925220279SA SV925220246SA SV925220252SA SV925220284SA SV925210155SA SV925220254SA SV925220258SA SV925220274SA SV925220283SA SV925220287SA SV925220245SA SV925220242SA SV925220289SA SV925220272SA SV9…
      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-0454-2026: GE Healthcare Finland Oy is recalling CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
text: The FDA logged enforcement record Z-0454-2026: GE Healthcare Finland Oy is voluntarily recalling CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001 — reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-26. Affected lots/codes: UDI-DI 00195278288639 Serial numbers SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV925080340SA SV925080281SA SV925080346SA SV925290119SA SV925290090SA SV925180134SA SV925160111SA SV925180131SA SV925180139SA SV925180140SA SV925180142SA SV925180143SA SV925180151SA SV925180152SA SV925160114SA SV925180141SA SV925180126SA SV925180132SA SV925180136SA SV925180135SA SV925180144SA SV925180146SA SV925180149SA SV925270007SA SV925260094SA SV925270009SA SV925270010SA SV925270008SA SV925260111SA SV925270003SA SV925270011SA SV925260085SA SV925260113SA SV925270001SA SV925270002SA SV925270006SA SV925270012SA SV925270005SA SV925270004SA SV925190002SA SV925180193SA SV925100151SA SV925100149SA SNA24400063SA SV925190009SA SV925200017SA SV925200028SA SV925190021SA SV925200022SA SV925200008SA SV925200015SA SV925200016SA SV925200021SA SV925200023SA SV925190014SA SV925200013SA SV925200012SA SV925200018SA SNA24162829SA SV925290115SA SV925220285SA SV925220291SA SV925220275SA SV925220267SA SV925220311SA SV925220240SA SV925220280SA SV925210129SA SV925220304SA SV925220255SA SV925220273SA …
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-0454-2026 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.