System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
Reason for recall: System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure. Distribution: Worldwide - US Nationwide distribution. Quantity: 1,799 US; 5,747 OUS Lot/code info: System Product Name - UDI-DI Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890; Azurion 3M15 - 00884838085282, 00884838099210; Azurion 5M12 - 00884838099227; Azurion 5M20 - 00884838099234; Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265; Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883; Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890; Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890; Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276; Software Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
00884838085275, 00884838099203, 00884838101890, 00884838085282, 00884838099210, 00884838099227, 00884838099234, 00884838059290, 00884838064775, 00884838085350, 00884838099265, 00884838059207, 00884838085367, 00884838099272, 00884838101883, 00884838085251, 00884838099241, 00884838059184, 00884838059191, 00884838059221, 00884838085268, 00884838086777, 00884838099258, 00884838103276
Official record: FDA (Device enforcement) ↗
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