fda_recall · device_recall · high
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.…
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:52:23Z
- Source ID
- Z-2286-2026
- Payload hash
- bb6ab0cf8167bc5e85a3e8ad…
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.