BiPAP V30 Auto Ventilator, Part Number 1111178
type: Dataset
description: FDA recall Z-1812-2024 — Philips Respironics, Inc. is recalling BiPAP V30 Auto Ventilator, Part Number 1111178 (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: BiPAP V30 Auto Ventilator, Part Number 1111178
  type: MedicalDevice
  manufacturer: Philips Respironics, Inc.
claims: FDA recall Z-1812-2024: Philips Respironics, Inc. is recalling BiPAP V30 Auto Ventilator, Part Number 1111178
claims: FDA classified recall Z-1812-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1812-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1812-2024
      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: UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DFC N205345727F67 N205345736EEE N205345741A51 N205345750BD8 N206864266FC0 N20686430132E N206864436CBD N206864671929 N20686470744E N2068647165C7 N20686472575C N2068647346D5 N20686474326A N206864761178 N2068647700F1 N20686478F806 N20686479E98F N20686482D494 N20686483C51D N20686484B1A2 N20686485A02B N2068648692B0 N206864878339 N206864887BCE N20713231EF66 N207132955432 N207133019FD2 N207134740972 N207134773BE9 N20713479D297 N205345615424 N20686469F057 N20686480F786 N207082010E5F N20713263B2CC N206864642BB2 N20686468E1DE N20…
      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

FDA recall Z-1812-2024: Philips Respironics, Inc. is recalling BiPAP V30 Auto Ventilator, Part Number 1111178
type: Claim
text: The FDA logged enforcement record Z-1812-2024: Philips Respironics, Inc. is voluntarily recalling BiPAP V30 Auto Ventilator, Part Number 1111178 — 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: UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DF…
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-1812-2024 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.