fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2…

Event date
2026-06-10 00:00:00Z
Observed
2026-07-09 22:52:22Z
Source ID
Z-2289-2026
Payload hash
840af92b360630d7f23a15d8

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.