BEUDAMED
    FDA Enforcement Class II Ongoing

    System INFX-8000F

    Recall: Z-1176-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1176-2021
    Event ID
    87419
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    February 5, 2021
    Classification Date
    March 9, 2021
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    System INFX-8000F

    Reason

    The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

    Code Info

    Model: CAS-880A, CAS-830B

    Distribution

    Nationwide

    Quantity

    272 in total