Trilogy Evo Universal Ventilator, Model Number DS2000X11B
type: Dataset
description: FDA recall Z-1652-2023 — Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model Number DS2000X11B (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: Trilogy Evo Universal Ventilator, Model Number DS2000X11B
  type: MedicalDevice
  manufacturer: Philips Respironics, Inc.
claims: FDA recall Z-1652-2023: Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model Number DS2000X11B
claims: FDA classified recall Z-1652-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1652-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1652-2023
      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: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-05-01
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963C57 H27742204CB4B H27742215C31A H27742217E008 H27742227CA60 H27742236C231 H27742240EA0F H27742245BDA2 H27742251E25E H27742262FAAD H27742273F2FC H2774229368EC H27742305801E H277423085BFB H27742321F58A H277423378964 H2774234293C1 H27742362A071 H277423691EA2 H27742377EE04 H277423823A61 H277423832BE8 H27742396659D H277424050C1B H277424072F09 H277424242E22 H277424253FAB H277424260D30 H27742428E44E H27742429F5C7 H27742439EC1F H2847032948F1 H28470375FC25 H284703930303 H28470409F744 H2847041707E2 H28470428D57D H284704444BC1 H284704647871 H284704828757 H284705573A5E H28470582DD8B H28470601CEB4 H28470617B25A H284706438AC6 H284706582DCD H284706832366 H284707019468 H28470716F90F H28470731BE00 H28470747963E H28470760D131 H28470776ADDF H28470810D6FE H28470823CE0D H284708493587 H284708609BF6 H28470998CEAA H284710122F95 H284710312EBE H2847105248F5 H284710727B45 H28471086BEA9 H284710984E0F H284711026C91 H28471105182E H2…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide. Global Distribution.
      status: recorded

FDA recall Z-1652-2023: Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model Number DS2000X11B
type: Claim
text: The FDA logged enforcement record Z-1652-2023: Philips Respironics, Inc. is voluntarily recalling Trilogy Evo Universal Ventilator, Model Number DS2000X11B — reason: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-01. Affected lots/codes: UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963C57 H27742204CB4B H27742215C31A H27742217E…
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-1652-2023 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.