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 2025-12-17; 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 R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTI…

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2025-12-17
License: https://argushq.ai/methodology

Event date: 2025-12-17 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0597-2026
Payload hash: 728fbc37c90b33db4f05a469…

Summary

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications. 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 2025-12-17; 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 (2025). Philips North America — Class II recall: Azurion R3.0.  Model Number 722234. Commercial Name: Azurion 7 M20.   INTERVENTI…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-z-0597-2026

MLA

"Philips North America — Class II recall: Azurion R3.0.  Model Number 722234. Commercial Name: Azurion 7 M20.   INTERVENTI…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-north-america-z-0597-2026.

Chicago

Argus HQ Research. "Philips North America — Class II recall: Azurion R3.0.  Model Number 722234. Commercial Name: Azurion 7 M20.   INTERVENTI…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-z-0597-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_z_0597_2026_2025,
  title = {Philips North America — Class II recall: Azurion R3.0.  Model Number 722234. Commercial Name: Azurion 7 M20.   INTERVENTI…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-z-0597-2026},
  note = {Accessed: July 17, 2026}
}

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