Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
type: Dataset
description: FDA recall Z-0456-2026 — GE Healthcare Finland Oy is recalling Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms (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: Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
  type: MedicalDevice
  manufacturer: GE Healthcare Finland Oy
claims: FDA recall Z-0456-2026: GE Healthcare Finland Oy is recalling Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
claims: FDA classified recall Z-0456-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0456-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0456-2026
      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 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA SWP25240013SA SWP25120633SA SWP25130746SA SWP25170056SA SWP25250034SA SWP25290065SA SWP25051286SA SWP25110533SA SWP25190088SA SWP25210044SA SWP25260155SA SWP25260156SA SWP25260157SA SWP25260158SA SWP25120623SA SWP25120627SA SWP25130766SA SWP25130843SA SWP25130844SA SWP25151063SA SWP25151071SA SWP25151087SA SWP25170027SA SWP25170028SA SWP25290048SA SWP25290053SA SWP25110399SA SWP25151065SA SWP25180130SA SWP25260120SA SWP25151070SA SWP25180126SA SWP25180127SA SWP25220010SA SWP25300001SA SWP25300002SA SWP25300003SA SWP25300004SA SWP25300005SA SWP25300006SA SWP25300007SA SWP25300008SA SWP25210078SA SWP25220050SA SWP25190090SA SWP25190091SA SWP25190092SA SWP25220063SA SWP25120626SA SWP25210082SA SWP25110389SA SWP25110390SA SWP25120616SA SWP25120617SA SWP25130744SA SWP25130745SA SWP25160028SA SWP25180128SA SWP25220023SA SWP25220024SA SWP25220025SA SWP25220026SA SWP25220027SA SWP25220028SA SWP25220029SA SWP25220030SA SWP25220031SA SWP25220032SA SWP25220034SA SWP25220035SA SWP25220036SA SWP252…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution.
      status: recorded

FDA recall Z-0456-2026: GE Healthcare Finland Oy is recalling Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
type: Claim
text: The FDA logged enforcement record Z-0456-2026: GE Healthcare Finland Oy is voluntarily recalling Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms — 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 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA SWP25240013SA SWP25120633SA SWP25130746SA SWP25170056SA SWP25250034SA SWP25290065SA SWP25051286SA SWP25110533SA SWP25190088SA SWP25210044SA SWP25260155SA SWP25260156SA SWP25260157SA SWP25260158SA SWP25120623SA SWP25120627SA SWP25130766SA SWP25130843SA SWP25130844SA SWP25151063SA SWP25151071SA SWP25151087SA SWP25170027SA SWP25170028SA SWP25290048SA SWP25290053SA SWP25110399…
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-0456-2026 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.