BEUDAMED
    FDA Recall Terminated

    GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

    Recall: Z-1709-2008 · Initiated July 2, 2008

    Recall

    Recall Number
    Z-1709-2008
    Event Number
    49483
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    July 2, 2008
    Posted
    September 20, 2008
    Terminated
    January 20, 2009
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

    Reason

    Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE

    Action

    Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.

    Distribution

    Nationwide Distribution including states of CA, FL, MS, and TX.

    Quantity

    660 units