BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2392-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2392-2023
    Event ID
    92664
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    June 22, 2023
    Classification Date
    August 10, 2023
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    Description

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

    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 Info

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

    Distribution

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

    Quantity

    12