BEUDAMED
    FDA Enforcement Class II Terminated

    Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    Recall: Z-0562-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0562-2014
    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 Vista/Vista Plus 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

    5652 5704 5758 5772 5792 5840 5653 5714 5759 5773 5796 5844 5654 5715 5760 5774 5798 5846 5655 5716 5761 5775 5805 5847 5656 5717 5762 5776 5809 5854 5695 5718 5763 5777 5810 5855 5696 5720 5764 5779 5814 5860 5697 5721 5765 5780 5816 5861 5698 5722 5766 5781 5823 5862 5699 5723 5767 5782 5828 5863 5700 5749 5768 5783 5830 5864 5701 5750 5769 5784 5833 5865 5702 5751 5770 5785 5838 5866 5703 5755 5771 5787 5839

    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

    83 devices