BEUDAMED
    FDA Recall Terminated

    Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia

    Recall: Z-0652-05 · Initiated February 24, 2005

    Recall

    Recall Number
    Z-0652-05
    Event Number
    31197
    Firm
    Compumedics Usa, Ltd
    FEI Number
    3002716534
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2005
    Posted
    March 24, 2005
    Terminated
    December 7, 2007
    Address
    7850 Paseo, Del Norte El Paso, TX, 79912

    Description

    Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia

    Reason

    Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.

    Action

    The firm initiated the recall on February 24, 2005 via letter with return response post card.

    Distribution

    Product was distributed nationwide and to the following foreign countries: Australia, Canada, Greece, Hong Kong, Hungary, India, Iran, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pillippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.

    Quantity

    1376 units