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 2026-02-18; 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 Llc — Class II recall: Spectral CT 7500 on Rails; Product Code (REF): 728334;

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2026-02-18
License: https://argushq.ai/methodology

Event date: 2026-02-18 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1318-2026
Payload hash: 9f2cdcac7bdab215d4195653…

Summary

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured o… 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 2026-02-18; 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 (2026). Philips North America Llc — Class II recall: Spectral CT 7500 on Rails;  Product Code (REF): 728334;. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1318-2026

MLA

"Philips North America Llc — Class II recall: Spectral CT 7500 on Rails;  Product Code (REF): 728334;." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-philips-north-america-llc-z-1318-2026.

Chicago

Argus HQ Research. "Philips North America Llc — Class II recall: Spectral CT 7500 on Rails;  Product Code (REF): 728334;." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1318-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_1318_2026_2026,
  title = {Philips North America Llc — Class II recall: Spectral CT 7500 on Rails;  Product Code (REF): 728334;},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1318-2026},
  note = {Accessed: July 17, 2026}
}

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