Reported Aug 16, 2023 · Ongoing
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
INFX-8000C XGCP-930AA TABLE SIDE CONSOLEINFX-8000C XGCP-930BA TABLE SIDE CONSOLE
- Lot codes and dates
- UDI-DI04987670100192. INFX-8000C
- Serial Numbers
BHA1992001BHB2132003SWC2242002AFB1832003SUC2262008SUC2292010BFB1972004SUB2172002SWC2262003
- Amount recalled
- 12
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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