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 2024-05-08; 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: The Oncology Essentials Package of the Spectral CT imaging system.

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2024-05-08
License: https://argushq.ai/methodology

Event date: 2024-05-08 00:00:00Z
Observed: 2026-07-16 23:20:11Z
Source ID: Z-1756-2024
Payload hash: 546d8d9a5d784b178eeef4a1…

Summary

Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. 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 2024-05-08; 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 North America Llc — Class II recall: The Oncology Essentials Package of the Spectral CT imaging system.. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1756-2024

MLA

"Philips North America Llc — Class II recall: The Oncology Essentials Package of the Spectral CT imaging system.." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-north-america-llc-z-1756-2024.

Chicago

Argus HQ Research. "Philips North America Llc — Class II recall: The Oncology Essentials Package of the Spectral CT imaging system.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1756-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_1756_2024_2024,
  title = {Philips North America Llc — Class II recall: The Oncology Essentials Package of the Spectral CT imaging system.},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1756-2024},
  note = {Accessed: July 17, 2026}
}

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