BEUDAMED
    FDA Enforcement Class II Terminated

    Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    Recall: Z-0565-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0565-2014
    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(2) 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

    9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815

    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

    54 devices