BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
type: Dataset
description: FDA recall Z-2037-2025 — Philips Respironics, Inc. is recalling BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS (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 A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
  type: MedicalDevice
  manufacturer: Philips Respironics, Inc.
claims: enforcement-record
claims: FDA classified recall Z-2037-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2037-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2037-2025
      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: This device does not indicate for use in patients with respiratory failure.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-05-09
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: US: A40 Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE21 V10271726A75B V10271727B6D2 V10307238112D V103072449649 V10307246B55B V10307252EAA7 V103072548F91 V10307256AC83 V10307257BD0A V103072595474 V10307260E3DD V10307261F254 V10307262C0CF V10307265B470 V103072679762 V103072697E1C V10307271EB8C V10307274BC21 V10086542359C V10307250C9B5 V10307251D83C V1030726686EB V10307410780C V103074134A97 V103074161D3A V103074304BBC V1030742143ED V10390418F201 V102716082749 V102716183E91 V103072485C25 V10307272D917 V10307273C89E V103074116985 V10307438C7F4 V104…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2037-2025: Philips Respironics, Inc. is recalling BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
text: The FDA logged enforcement record Z-2037-2025: Philips Respironics, Inc. is voluntarily recalling BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS — reason: This device does not indicate for use in patients with respiratory failure.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-09. Affected lots/codes: US: A40 Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE21 V10271726A75B V10271727B6D2 V10307238112D V103072449649…
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-2037-2025 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.