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 2023-04-12; 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.

.hq

fda_recall · device_recall · critical

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

Name: FDA Recall Record — Philips Respironics, Inc.
Creator: Argus HQ
Published: 2023-04-12
License: https://argushq.ai/methodology

Event date: 2023-04-12 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-1289-2023
Payload hash: 0270011cd9c0484c769e1a6c…

Summary

The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of o… Status: Ongoing.

Entities

Philips Respironics, Inc.

View source record ↗

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 2023-04-12; 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 Portable Electric Ventilator, Model Number DS2000X11B. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1289-2023

MLA

"Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-respironics-inc-z-1289-2023.

Chicago

Argus HQ Research. "Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1289-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_respironics_inc_z_1289_2023_2023,
  title = {Philips Respironics, Inc. — Class I recall: Trilogy Evo Universal Portable Electric 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-1289-2023},
  note = {Accessed: July 17, 2026}
}

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