FDA-Device2023-08-16Class II
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Canon Medical System, USA, INC.
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.
Sold states
US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
Affected count
12
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2023Don't want to check this manually?
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