BEUDAMED
    FDA Recall Terminated

    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862

    Recall: Z-0181-2008 · Initiated March 23, 2007

    Recall

    Recall Number
    Z-0181-2008
    Event Number
    37661
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    March 23, 2007
    Posted
    November 10, 2007
    Terminated
    April 16, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862

    Reason

    Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.

    Action

    Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.

    Distribution

    Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kong, Italy, Japan, Mexico, and Spain.

    Quantity

    61 units