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Recall Observatory FDA recall evidence

Device product

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

Z-2392-2023

June 22, 2023

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 92664
Status
Ongoing
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-2392-2023

Official wording

Reason: 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.

Code information: UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003

Distribution pattern: US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.