BEUDAMED
    FDA Enforcement Class II Ongoing

    Digital Angiography System Bransist safire Generator Model D150GC-40

    Recall: Z-0654-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0654-2022
    Event ID
    89253
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    December 16, 2021
    Classification Date
    February 27, 2022
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328, United States

    Description

    Digital Angiography System Bransist safire Generator Model D150GC-40

    Reason

    Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

    Code Info

    Generator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581

    Distribution

    U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

    Quantity

    18