PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 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: 156 units Lot/code info: UDI (01)00884838085367(21)547, (01)00884838099272(21)120, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099272(21)124, (01)00884838099272(21)125, (01)00884838099272(21)126, (01)00884838099272(21)127, (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)209, (01)00884838099272(21)271, (01)00884838099272(21)675, (01)00884838099272(21)112, (01)00884838085367(21)467, (01)00884838085367(21)335, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838099272(21)139, (01)00884838099272(21)158, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838099272(21)678, (01)00884838099272(21)362, (01)00884838099272(21)114, (01)00884838085367(21)564, (01)00884838099272(21)403, (01)00884838085367(21)418, (01)00884838085367(21)440, (01)00884838099272(21)108, (01)00884838099272(21)545, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838099272(21)281, (01)00884838099272(21)495, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099272(21)183, (01)00884838085367(21)64, (01)00884838099272(21)325, (01)00884838099272(21)100, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)42, (01)00884838099272(21)255, (01)00884838099272(21)341, (01)00884838099272(21)687, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838085367(21)323, (01)00884838099272(21)270, (01)00884838099272(21)254, (01)0088483809

UPC codes

00884838085367, 00884838099272

Source

Official record: FDA (Device enforcement) ↗

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