BEUDAMED
    FDA Enforcement Class II Ongoing

    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

    Recall: Z-0869-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0869-2022
    Event ID
    89596
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    January 10, 2022
    Classification Date
    April 6, 2022
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328, United States

    Description

    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

    Reason

    It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

    Code Info

    Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013

    Distribution

    U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A

    Quantity

    12 systems