BEUDAMED
    FDA Enforcement Class II Ongoing

    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

    Recall: Z-0655-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0655-2022
    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 Shimadzu Trinias 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 - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A

    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

    28 systems