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 high severity by Argus HQ. FDA published the underlying record on 2024-01-10; 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 · high

Philips Respironics, Inc. — Class II recall: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X…

Name: FDA Recall Record — Philips Respironics, Inc.
Creator: Argus HQ
Published: 2024-01-10
License: https://argushq.ai/methodology

Event date: 2024-01-10 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-0638-2024
Payload hash: 937e6eb02878d6d000235536…

Summary

The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include… 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 high severity by Argus HQ. FDA published the underlying record on 2024-01-10; 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 (2024). Philips Respironics, Inc. — Class II recall: Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0638-2024

MLA

"Philips Respironics, Inc. — Class II recall: Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-respironics-inc-z-0638-2024.

Chicago

Argus HQ Research. "Philips Respironics, Inc. — Class II recall: Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0638-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_respironics_inc_z_0638_2024_2024,
  title = {Philips Respironics, Inc. — Class II recall: Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0638-2024},
  note = {Accessed: July 17, 2026}
}

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