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fda_recall · device_recall · critical

Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Event date
2023-06-14 00:00:00Z
Observed
2026-07-16 23:20:13Z
Source ID
Z-1652-2023
Payload hash
8ac450ad4a886b11dde538fb

Summary

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,… Status: Ongoing.

Frequently asked questions

Has Philips Respironics, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 50 total FDA actions tied to Philips Respironics, Inc.: 0 warning letters, 50 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-06-14; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2023). Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Ventilator, Model Number DS2000X11B. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1652-2023
MLA
"Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Ventilator, Model Number DS2000X11B." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-respironics-inc-z-1652-2023.
Chicago
Argus HQ Research. "Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Ventilator, Model Number DS2000X11B." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1652-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_respironics_inc_z_1652_2023_2023,
  title = {Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Ventilator, Model Number DS2000X11B},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1652-2023},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.