BEUDAMED
    FDA Recall Terminated

    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

    Recall: Z-2643-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-2643-2016
    Event Number
    74013
    Firm
    Ziehm Imaging Inc
    FEI Number
    2027299
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 15, 2016
    Terminated
    July 18, 2019
    Address
    6280 Hazeltine National Dr, Ste 100, Orlando, FL, 32822-5114

    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.

    Action

    Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.

    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