BEUDAMED
    FDA Enforcement Class II Ongoing

    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

    Recall: Z-1289-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1289-2022
    Event ID
    90246
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    May 3, 2022
    Classification Date
    June 24, 2022
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

    Reason

    CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

    Code Info

    UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648

    Distribution

    U.S.: CA, CO, FL, NY, and WY O.U.S.: None

    Quantity

    6 systems