BEUDAMED
    FDA Enforcement Class II Terminated

    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

    Recall: Z-2643-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2643-2016
    Event ID
    74013
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ziehm Imaging Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    April 15, 2016
    Classification Date
    August 25, 2016
    Termination Date
    July 18, 2019
    Address
    6280 Hazeltine National Dr Ste 100, Orlando, FL, 32822-5114, United States

    Description

    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

    Reason

    Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

    Code Info

    Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

    Distribution

    US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

    Quantity

    12 devices