BEUDAMED
    FDA Enforcement Class II Ongoing

    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

    Recall: Z-0554-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0554-2021
    Event ID
    86846
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2020
    Initiation Date
    November 18, 2020
    Classification Date
    December 10, 2020
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    Description

    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

    Reason

    The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

    Code Info

    Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901

    Distribution

    US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.

    Quantity

    7 units