Has PHILIPS MEDICAL SYSTEMS had other FDA enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to PHILIPS MEDICAL SYSTEMS: 0 warning letters, 8 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 2025-11-05; 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 MEDICAL SYSTEMS — Class II recall: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1…

Name: FDA Recall Record — PHILIPS MEDICAL SYSTEMS
Creator: Argus HQ
Published: 2025-11-05
License: https://argushq.ai/methodology

Event date: 2025-11-05 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0376-2026
Payload hash: 1edc67a943ff9871c9721214…

Summary

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself… Status: Ongoing.

Entities

PHILIPS MEDICAL SYSTEMS

View source record ↗

Frequently asked questions

Has PHILIPS MEDICAL SYSTEMS had other FDA enforcement actions?: Yes. Argus HQ has recorded 8 total FDA actions tied to PHILIPS MEDICAL SYSTEMS: 0 warning letters, 8 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 2025-11-05; 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 MEDICAL SYSTEMS — Class II recall: Model: CT 5300;  Product Code (REF): 728285;  Software Versions: 5.1.0.X & 5.1.1…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-z-0376-2026

MLA

"PHILIPS MEDICAL SYSTEMS — Class II recall: Model: CT 5300;  Product Code (REF): 728285;  Software Versions: 5.1.0.X & 5.1.1…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-medical-systems-z-0376-2026.

Chicago

Argus HQ Research. "PHILIPS MEDICAL SYSTEMS — Class II recall: Model: CT 5300;  Product Code (REF): 728285;  Software Versions: 5.1.0.X & 5.1.1…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-z-0376-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_z_0376_2026_2025,
  title = {PHILIPS MEDICAL SYSTEMS — Class II recall: Model: CT 5300;  Product Code (REF): 728285;  Software Versions: 5.1.0.X & 5.1.1…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-z-0376-2026},
  note = {Accessed: July 17, 2026}
}

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