Trilogy Evo Universal Ventilator, Model No. DS2000X11B
type: Dataset
description: FDA recall Z-2943-2024 — Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model No. 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 No. DS2000X11B
  type: MedicalDevice
  manufacturer: Philips Respironics, Inc.
claims: FDA recall Z-2943-2024: Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model No. DS2000X11B
claims: FDA classified recall Z-2943-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2943-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2943-2024
      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: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-16
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 606959052000 US Serial Numbers H28984740CF4E H28984800E2E9 H3069350132A0 H30753614E0AA H30789237223A H307892401B8D H307892445DA9 H307892476F32 H307892646E19 H307892657F90 H30789268A475 H30789269B5FC H30803946EC1A H308039813105 H308040536950 H308040753FD6 H30804091E3E2 H30804129D1DE H3081539229E2 H3081768676D5 H30817950E95C H3081837986AE H30828473B83D H30828515D307 H30835691344C H308357380E21 H308357448945 H30835753E422 H30835756B38F H30835772C61B H3083577791B6 H308357786941 H30835794393D H30835853AEE5 H3083585901BF H30835863848D H30835900B81A H30882857F80C H308829934D54 H308830388E52 H308830607CA2 H30883068F0EA H3088307532D7 H308830868384 H30883094B94E H30883120411E H30883128CD56 H30883139C507 H308831511D9F H3088315991D7 H308831703FA6 H30883178B3EE H308831883026 H308832009DCA H308862087FD5 H308862179EFA H30886226A51B H30886231C87C H308862418574 H30886253BFBE H308862682B05 H30886334C50D H30886337F796 H308863391EE8 H30886342ED33 H308863448805 H3088634953E0 H30886353E562 H30886363CF0A H30886371F5C0 H308863817608 H308864130E07 H308864377B93 H30886449DFE5 H3088646437B0 H308864735AD7 H30886484ADA0 H308864987E14 H308865070B27 H30886519FB81 H30886529D1E9 H3088656319D3 H30886573000B H3088658383C3 H308866090D3D H30886616EC12 H30886624E568 H30886635ED39 H30886643C507 H308866487BD4 H30886661D5A5 H308866684864 H308866814FB5 H30886689C3FD H3088669401C0 H308867690331 H30886775D085 H308867780B60 H308867791AE9 H308867901D38 H30886830AA8F H30886840E787 H308868486BCF H308868587217 H3088686949F6 H30886876A8D9 H30889425F3A0 H30889434FBF1 H308894850ED0 H30889562BAA3 H308895844585 H308895967F4F H30889609BFC4 H308896267483 H30896192E3B7 H30896196A593 H308961984CED H30896201E950 H30896203CA42 H3090220588D7 H30902206BA4C H3090220942BB H309022438A81 H30902245EFB7 H30902247CCA5 H30902250A1C2 H30902251B04B H3090225282D0 H309022539359 H30908936652C H3090895277D8 H30908970677A H309091168CE5 H30909136BF55 H30909157FA0C H309091920401 H309122691D2F H30912295548B H30912321ACDB H3091234865CA H…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.
      status: recorded

FDA recall Z-2943-2024: Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator, Model No. DS2000X11B
type: Claim
text: The FDA logged enforcement record Z-2943-2024: Philips Respironics, Inc. is voluntarily recalling Trilogy Evo Universal Ventilator, Model No. DS2000X11B — reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-16. Affected lots/codes: UDI-DI: 606959052000 US Serial Numbers H28984740CF4E H28984800E2E9 H3069350132A0 H30753614E0AA H30789237223A H307892401B8D H307892445DA9 H307892476F32 H307892646E19 H307892657F90 H30789268A475 H30789269B5FC H30803946EC1A H308039813105 H308040536950 H308040753FD6 H30804091E3E2 H30804129D1DE H3081539229E2 H3081768676D5 H30817950E95C H3081837986AE H30828473B83D H30828515D307 H30835691344C H308357380E21 H308357448945 H30835753E422 H30835756B38F H30835772C61B H3083577791B6 H308357786941 H30835794393D H30835853AEE5 H3083585901BF H30835863848D H30835900B81A H30882857F80C H308829934D54 H308830388E52 H308830607CA2 H30883068F0EA H3088307532D7 H308830868384 H30883094B94E H30883120411E H30883128CD56 H30883139C507 H308831511D9F H3088315991D7 H308831703FA6 H30883178B3EE H308831883026 H308832009DCA H308862087FD5 H308862179EFA H30886226A51B H30886231C87C H308862418574 H30886253BFBE H308862682B05 H30886334C50D H30886337F796 H308863391EE8 H30886342ED33 H308863448805 H3088634953E0 H30886353E562 H30886363CF0A H30886371F5C0 H308863817608 H308864130E07 H308864377B93 H30886449DFE5 H3088646437B0 H308864735AD7 H30886484ADA0 H308864987E14 H308865070B27 H30886519FB81 H30886529D1E9 H3088656319D3 H30886573000B H3088658383C3 H308866090D3D H30886616EC12 H30886624E568 H30886635ED39 H30886643C507 H308866487BD4 H30886661D5A5 H308866684864 H308866814FB5 H30886689C3FD H3088669401C0 H308867690331 H30886775D085 H308867780B60 H308867791AE9 H308867901D38 H30886830AA8F H30886840E787 H308868486BCF H308868587217 H3088686949F6 H30886876A8D9 H30889425F3A0 H30889434FBF1…
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-2943-2024 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.