BEUDAMED
    FDA Enforcement Class II Ongoing

    MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

    Recall: Z-0867-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0867-2022
    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 R/F SYSTEM FLUOROspeed X1

    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: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002

    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

    25 systems