BEUDAMED
    FDA Recall Terminated

    InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    Recall: Z-0524-2014 · Initiated November 26, 2013

    Recall

    Recall Number
    Z-0524-2014
    Event Number
    66992
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    November 26, 2013
    Posted
    December 17, 2013
    Terminated
    April 17, 2017
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    Reason

    GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

    Action

    GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.

    Distribution

    Nationwide Distribution

    Quantity

    654