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

Yes. Argus HQ has recorded 205 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 205 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 2026-06-10; Argus observed and indexed it on 2026-07-09.

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: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.…

Name: FDA Recall Record — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Creator: Argus HQ
Published: 2026-06-10
License: https://argushq.ai/methodology

Event date: 2026-06-10 00:00:00Z
Observed: 2026-07-09 22:52:19Z
Source ID: Z-2290-2026
Payload hash: 48c9b6ac5adb21ab54f4f9f3…

Summary

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoro… 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 205 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 205 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 2026-06-10; Argus observed and indexed it on 2026-07-09.
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 MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers:  722078, 722223 with Software release R2.2.…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-2290-2026

MLA

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers:  722078, 722223 with Software release R2.2.…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-2290-2026.

Chicago

Argus HQ Research. "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers:  722078, 722223 with Software release R2.2.…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-2290-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_nederland_b_v_z_2290_2026_2026,
  title = {PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers:  722078, 722223 with Software release R2.2.…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-2290-2026},
  note = {Accessed: August 27, 2026}
}

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