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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 3 units Lot/code info: UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.

UPC codes

00884838099227

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.