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 2024-11-20; 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 O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA…

Name: FDA Recall Record — Philips Respironics, Inc.
Creator: Argus HQ
Published: 2024-11-20
License: https://argushq.ai/methodology

Event date: 2024-11-20 00:00:00Z
Observed: 2026-07-16 23:20:11Z
Source ID: Z-0290-2025
Payload hash: 6175e7581dce0dfab851c4c8…

Summary

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. 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 2024-11-20; 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 I recall: Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0290-2025

MLA

"Philips Respironics, Inc. — Class I recall: Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-respironics-inc-z-0290-2025.

Chicago

Argus HQ Research. "Philips Respironics, Inc. — Class I recall: Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0290-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_respironics_inc_z_0290_2025_2024,
  title = {Philips Respironics, Inc. — Class I recall: Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-respironics-inc-z-0290-2025},
  note = {Accessed: July 17, 2026}
}

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