Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?

Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 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 2025-06-18; 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 MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 72206…

Name: FDA Recall Record — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Creator: Argus HQ
Published: 2025-06-18
License: https://argushq.ai/methodology

Event date: 2025-06-18 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1969-2025
Payload hash: 2b28b09f6e32484cc7faf996…

Summary

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay m… Status: Ongoing.

Entities

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

View source record ↗

Frequently asked questions

Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?: Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 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 2025-06-18; 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 (2025). PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems;  Model Numbers: (1) 722063, (2) 722064, (3) 72206…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1969-2025

MLA

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems;  Model Numbers: (1) 722063, (2) 722064, (3) 72206…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1969-2025.

Chicago

Argus HQ Research. "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems;  Model Numbers: (1) 722063, (2) 722064, (3) 72206…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1969-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_nederland_b_v_z_1969_2025_2025,
  title = {PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems;  Model Numbers: (1) 722063, (2) 722064, (3) 72206…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1969-2025},
  note = {Accessed: July 17, 2026}
}

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