medical Class II Updated 2022-01-19

Philips North America Llc recalls Philips Azurion Interventional Fluoroscopic X-ray System wit

Recalled Product

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Hazard / Issue

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220
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