OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
type: Dataset
description: FDA recall Z-1817-2024 — Philips Respironics, Inc. is recalling OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 (Devices, Class I). 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: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
  type: MedicalDevice
  manufacturer: Philips Respironics, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1817-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1817-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1817-2024
      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 I
      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: Philips Respironics, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-01
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8 L09796818D7B6 L09796819C63F L097968225284 L09796823430D L0979682437B2 L09796825263B L097968270529 L09796829EC57 L0979684751F9 L09796849B887 L097968512D17 L097968521F8C L0981390546A9 L098140911CAA L098141339814 L100102519380 L10010275E614 L1001028123F8 L1001028565DC L1001028746CE L10010288BE39 L100102913A20 L100102975F16 L1001030394F6 L10010310BFB5 L100103138D2E L10010338004D L1001034596A0 L100103558F78 L1001039705CA L100104165686 L10010417470F L100104223ACA L100104300000 L103082023D42 L103905201559 L10638229B96A L1063826260D9 L106382750DBE L10638290C003 L106383073978 L106383114596 L1087900826E2 L10879015E4DF L11022823358F L1102293730AF L110456413EEF L110706047DB9 L110708377551 L11070894BABA L11070899615F L11070900715A L11070906146C L110709489A72 L110709500FE2 L11081466C984 L110815129874 L110815290CCF L110815669358 L110817023414 L11136407983B L112492807AC5 L11249288F68D L11249292400F L112492935186 L112492942539 L11249296062B L1124929717A2 L11249299FEDC L11249304A8FD L112493086291 L11249312D413 L122858118744 L12735071463D L12945235DBBF L1323076570C1 L13230766425A L1323076753D3 L13230768AB24 L13230769BAAD L1330033132DB L13300393ECB9 L186537949AFB L18653797A860 L21271600A5A0 L22035135ABA4 L22035136993F L220351387041 L2203513961C8 L22226897CF07 L2222689837F0 L22977035C06D L229770390A01 L22977042F9DA L22977043E853 L229770449CEC L229770458D65 L22977046BFFE L22977047AE77 L229770485680 L229770494709 L22977050C310 L22977051D299 ; 1111123 / UDI-DI 606959067820 Serial Numbers L111838125A56 L11249556238E L113839345E5A L114895520A60 L11489624CD3A L122772495544 L12277265AC98 L122820001EF6 L122820010F7F L122820023DE4 L12600251B785 L12600256C33A L14644753AA1B L14644754DEA4 L150166760CD7 L150166771D5E L15229405619F L16241620C614 L16241621D79D L1624…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution and OUS International distribution to Canada.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1817-2024: Philips Respironics, Inc. is recalling OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
text: The FDA logged enforcement record Z-1817-2024: Philips Respironics, Inc. is voluntarily recalling OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 — reason: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-01. Affected lots/codes: Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8 L09796818D7B6 L09796819C63F L097968225284 L09796823430D L0979682437B2 L09796825263B L097968270529 L09796829EC57 L0979684751F9 L09796849B887 L097968512D17 L097968521F8C L0981390546A9 L098140911CAA L098141339814 L100102519380 L10010275E614 L1001028123F8 L1001028565DC L1001028746CE L10010288BE39 L100102913A20 L100102975F16 L1001030394F6 L10010310BFB5 L100103138D2E L10010338004D L1001034596A0 L100103558F78 L1001039705CA L100104165686 L10010417470F L100104223ACA L100104300000 L103082023D42 L103905201559 L10638229B96A L1063826260D9 L106382750DBE L10638290C003 L106383073978 L106383114596 L1087900826E2 L10879015E4DF L11022823358F L1102293730AF L110456413EEF L110706047DB9 L110708377551 L11070894BABA L11070899615F L11070900715A L11070906146C L110709489A72 L110709500FE2 L11081466C984 L110815129874 L110815290CCF L110815669358 L110817023414 L11136407983B L112492807AC5 L11249288F68D L11249292400F L112492935186 L112492942539 L11249296062B L1124929717A2 L11249299FEDC L11249304A8FD L112493086291 L11249312D413 L122858118744 L12735071463D L12945235DBBF L1323076570C1 L13230766425A L1323076753D3 L13230768AB24 L13230769BAAD L1330033132DB L13300393ECB9…
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-1817-2024 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.