BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2392-2023 · Initiated June 22, 2023

    Recall

    Recall Number
    Z-2392-2023
    Event Number
    92664
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2023
    Posted
    August 11, 2023
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    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.

    Action

    On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to replace the PWB on the console. Complete and return the customer reply form to [email protected] For questions, contact the InTouch team at [email protected] or your service representative at 800.521.1968

    Distribution

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

    Quantity

    12