fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.…

Event date
2026-06-10 00:00:00Z
Observed
2026-07-09 22:52:20Z
Source ID
Z-2291-2026
Payload hash
4b879baf50a69995758f2baf

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.

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