FDA recall Z-2392-2023

Canon Medical System, USA, INC. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-06-22
Report date
2023-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2023