BEUDAMED
    FDA Enforcement Class II Terminated

    Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    Recall: Z-0564-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0564-2014
    Event ID
    66976
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ziehm Imaging Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    November 21, 2013
    Classification Date
    December 24, 2013
    Termination Date
    June 23, 2014
    Address
    6280 Hazeltine National Dr, Suite 100, Orlando, FL, 32822-5114, United States

    Description

    Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    Reason

    Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

    Code Info

    9209 9277 9448 9584 9655 9211 9278 9459 9585 9656 9212 9279 9475 9586 9657 9214 9315 9478 9587 9658 9216 9316 9506 9588 9659 9217 9343 9514 9633 9660 9245 9352 9530 9634 9664 9246 9358 9531 9645 9665 9255 9376 9551 9646 9666 9256 9377 9562 9647 9672 9272 9404 9571 9653 97119273 9427 9582 9654 9728

    Distribution

    USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.

    Quantity

    60 devices