FDAHealthDecember 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
⚠️ 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 fluoroscopy run.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 7, 2023
US Nationwide distribution.
What's affected?
- Product
- Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- Lot code
- UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.
Additional details
UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.
What should I do?
Recommended action
Class II recall. Quantity affected: 3 units.
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