BEUDAMED
    FDA Enforcement Class II Terminated

    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

    Recall: Z-2060-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2060-2018
    Event ID
    80067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    June 14, 2018
    Termination Date
    February 24, 2022
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    Description

    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

    Reason

    When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.

    Code Info

    Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002

    Distribution

    US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.

    Quantity

    17