Z-1814-2024.jsonld
type: Dataset
name: BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
description: FDA recall Z-1814-2024 — Philips Respironics, Inc. is recalling BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181 (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: MedicalDevice
  name: BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
  manufacturer: Philips Respironics, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1814-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1814-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1814-2024
      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: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-03-26
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD N097653679F24 N102712420C4C N102712431DC5 N1027125470A2 N10271255612B N1027125653B0 N10271258BACE N10271259AB47 N102712601CEE N102712610D67 N102712623FFC N102712632E75 N102712654B43 N1027126679D8 N1027126890A6 N102712700536 N1027127114BF N10271275529B N102712777189 N10271282A5EC N10271283B465 N10271285D153 N10271287F241 N102712880AB6 N102712891B3F N102712909F26 N10271292BC34 N10271293ADBD N10271294D902 N10271295C88B N10271297EB99 N10271298136E N1027129902E7 N1027130012E2 N10271307665D N102713089EAA N102713100B3A N102713122828 N102713155C97 N102713177F85 N1027131996FB N1027132313C9 N1027132576FF N10271329BC93 N102713356F27 N102713365DBC N102713374C35 N102713517DD3 N10271356096C N102713626520 N102713714E63 N102713727CF8 N10271390C5FA N10271410873F N1027141196B6 N10271413B5A4 N10271428211F N10271439294E N10271440F987 N10271442DA95 N10271443CB1C N102714496446 N10271473E174 N1027147495CB N102714758442 N10271476B6D9 N10271477A750 N102714794E2E N102714841603 N10271489CDE6 N102714926AED N102714951E52 N10271499D43E N10271503F6A0 N10271504821F N102715059396 N10271506A10D N10271511CC6A N10271513EF78 N1027151851AB N10271520F78B N10271521E602 N10271522D499 N10271523C510 N10271524B1AF N102715278334 N10271530EE53 N10271531FFDA N10271533DCC8 N102715368B65 N102715379AEC N102715397392 N102715428049 N1027154391C0 N10271547D7E4 N102715482F13 N10271550BA83 N10271551AB0A N102715538818 N10271554FCA7 N10271556DFB5 N10271557CE3C N1027156090EB N102715618162 N10271563A270 N10271565C746 N10271566F5DD N102715681CA3 N102715690D2A N102715708933 N1027157198BA N10271573BBA8 N10271576EC05 N102715811B72 N1027158229E9 N102715844CDF N102715855D56 N102715866FCD N102715877E44 N102715901323 N1027159102AA N1027159321B8 N102715967615 N102715998EE2 N102716002B5F N10271602084D N10…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1814-2024: Philips Respironics, Inc. is recalling BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
text: The FDA logged enforcement record Z-1814-2024: Philips Respironics, Inc. is voluntarily recalling BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181 — reason: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-26. Affected lots/codes: US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD N097653679F24 N102712420C4C N102712431DC5 N1027125470A2 N10271255612B N1027125653B0 N10271258BACE N10271259AB47 N102712601CEE N102712610D67 N102712623FFC N102712632E75 N102712654B43 N1027126679D8 N1027126890A6 N102712700536 N1027127114BF N10271275529B N102712777189 N10271282A5EC N10271283B465 N10271285D153 N10271287F241 N102712880AB6 N102712891B3F N102712909F26 N10271292BC34 N10271293ADBD N10271294D902 N10271295C88B N10271297EB99 N10271298136E N1027129902E7 N1027130012E2 N10271307665D N102713089EAA N102713100B3A N102713122828 N102713155C97 N102713177F85 N1027131996FB N1027132313C9 N1027132576FF N10271329BC93 N102713356F27 N102713365DBC N102713374C35 N102713517DD3 N10271356096C N102713626520 N102713714E63 N102713727CF8 N10271390C5FA N10271410873F N1027141196B6 N10271413B5A4 N10271428211F N10271439294E N10271440F987 N10271442DA95 N10271443CB1C N102714496446 N10271473E174 N1027147495CB N102714758442 N10271476B6D9 N10271477A750 N102714794E2E N102714841603 N10271489CDE6 N102714926AED N102714951E52 N10271499D43E N10271503F6A0 N10271504821F N102715059396 N10…
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-1814-2024 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.