fda_recall · device_recall · high
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.…
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:52:19Z
- Source ID
- Z-2287-2026
- Payload hash
- 35e6993249fce3c75eb4bf04…
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.