BEUDAMED
    FDA Recall Terminated

    ENTrak Plus Navigation and Visualization System

    Recall: Z-0688-05 · Initiated December 13, 2004

    Recall

    Recall Number
    Z-0688-05
    Event Number
    30758
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 13, 2004
    Posted
    April 8, 2005
    Terminated
    July 8, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    ENTrak Plus Navigation and Visualization System

    Reason

    Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

    Action

    Customers were notified by letter on 12/13/04.

    Distribution

    Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.

    Quantity

    67 units