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fda_recall · device_recall · critical

Philips Respironics, Inc. — Class I recall: Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric…

Event date
2024-04-24 00:00:00Z
Observed
2026-07-16 23:20:11Z
Source ID
Z-1502-2024
Payload hash
dcc1ea07a58e631af66f1396

Summary

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. 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 2024-04-24; 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 EV300, all software versions except 1.05.06.00. Ventilator for pediatric…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1502-2024
MLA
"Philips Respironics, Inc. — Class I recall: Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-respironics-inc-z-1502-2024.
Chicago
Argus HQ Research. "Philips Respironics, Inc. — Class I recall: Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1502-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_respironics_inc_z_1502_2024_2024,
  title = {Philips Respironics, Inc. — Class I recall: Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-respironics-inc-z-1502-2024},
  note = {Accessed: July 17, 2026}
}

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