Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Reason for recall: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure Distribution: Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Quantity: USA: 1063 R.O.W. 2136 Lot/code info: UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion SM12: 722227 (01)00884838099227(21); (4) Azurion SM20: 722228 (01)00884838099234(21); (5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
00884838085275, 00884838099203, 00884838085282, 00884838099210, 00884838099227, 00884838099234, 00884838085350, 00884838099265, 00884838085367, 00884838099272, 00884838085251, 00884838099241, 00884838085268, 00884838099258
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.