BEUDAMED
    FDA Recall Terminated

    Gyroscan ACS-NT system

    Recall: Z-1199-03 · Initiated May 2, 2002

    Recall

    Recall Number
    Z-1199-03
    Event Number
    26579
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 2, 2002
    Posted
    September 12, 2003
    Terminated
    April 11, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Gyroscan ACS-NT system

    Reason

    Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil

    Action

    The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.

    Distribution

    The firm distributed units to hospitals and medical centers nationwide.

    Quantity

    112 total for all 3 devices