medical Class II Updated 2023-08-16

Canon Medical System, USA, INC. recalls INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-9

Recalled Product

INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE


Hazard / Issue

The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
View official government recall

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