Z-1649-2023.jsonld
type: Dataset
name: Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
description: FDA recall Z-1649-2023 — Philips Respironics, Inc. is recalling Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B (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: Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
  manufacturer: Philips Respironics, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1649-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1649-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1649-2023
      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: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
      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: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 H31735981C50F H317406346246 H3174065070B2 H317406543696 H317406740526 H31740679DEC3 H31740686A5FC H31740691C89B H31740696BC24 H31740701455F H317964963E72 H318068788452 H31806883B949 H31806884CDF6 H31806885DC7F H31806888079A H318368546042 H3183685571CB H318368564350 H31836858AA2E H31861740040C H3186181302E8 H318619467121 H3186198831FF H31862000CAA4 H31961173CE0D H320015337C89 H320015731BE9 H3204332184FC H32043326F043 H32107976A656 H321079795EA1 H321542678438 H321542687CCF H322097635A07 H32209769F55D H3220978697BA H32209790EB54 H322097968E62 H3220980430AF H322098117EDA H32209818E31B H322581438581 H32258144F13E H32258145E0B7 H32258146D22C H32258147C3A5 H323157817B5E H32315798FF47 H32315830C4B8 H32315965B771 H323159861FFA H323160033F44 H323160203E6F H3231604249AD H32316060590F H32316078CC9F H3231612247A1 H32316139E0AA H32316159B47A H32316167776C H32316185CE6E H323161890402 H323172129E16 H3231723802FC H32317242E0AE H3231726784B3 H32317301EF89 H32317305A9AD H32317310E7D8 H3231733583C5 H3231734…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide. Global Distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1649-2023: Philips Respironics, Inc. is recalling Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
text: The FDA logged enforcement record Z-1649-2023: Philips Respironics, Inc. is voluntarily recalling Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B — reason: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-01. Affected lots/codes: UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 H31735981C50F H317406346246 H3174065070B2 H317406543696 H317406740526 H31740679DEC3 H31740686A5FC H31740691C89B H31740696BC24 H31740701455F H317964963E72 H318068788452 H31806883B949 H31806884CDF6 H3180688…
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-1649-2023 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.