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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA Quantity: 12 Lot/code info: UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003

UPC codes

04987670100192

Source

Official record: FDA (Device enforcement) ↗

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