PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M20, Model Numbers: 722079, 722224 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: 31 units Lot/code info: UDI (01)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475.

UPC codes

00884838099258, 00884838085268

Source

Official record: FDA (Device enforcement) ↗

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