BEUDAMED
    FDA Recall Terminated

    OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging

    Recall: Z-0974-2017 · Initiated December 19, 2016

    Recall

    Recall Number
    Z-0974-2017
    Event Number
    76033
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    December 19, 2016
    Posted
    January 9, 2017
    Terminated
    August 22, 2017
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging

    Reason

    GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

    Action

    GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. For questions regarding this recall call 801-536-4952.

    Distribution

    Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica