BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0568-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0568-2014
    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 RFD 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

    20006 20025 20142 20185 20216 20231 20015 20026 20151 20186 20217 20236 20016 20027 20153 20189 20225 20018 20031 20166 20198 20227 20019 20139 20184 20199 20228

    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

    27 devices