Has Philips North America had other FDA enforcement actions?

Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 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 2023-11-15; 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 North America — Class II recall: Azurion IGTS Fixed Systems

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2023-11-15
License: https://argushq.ai/methodology

Event date: 2023-11-15 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-0229-2024
Payload hash: 0a7c85200075d21ea7d744f4…

Summary

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing. Status: Ongoing.

Entities

Philips North America

View source record ↗

Frequently asked questions

Has Philips North America had other FDA enforcement actions?: Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 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 2023-11-15; 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 North America — Class II recall: Azurion IGTS Fixed Systems. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-z-0229-2024

MLA

"Philips North America — Class II recall: Azurion IGTS Fixed Systems." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-north-america-z-0229-2024.

Chicago

Argus HQ Research. "Philips North America — Class II recall: Azurion IGTS Fixed Systems." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-z-0229-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_z_0229_2024_2023,
  title = {Philips North America — Class II recall: Azurion IGTS Fixed Systems},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-z-0229-2024},
  note = {Accessed: July 17, 2026}
}

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