BEUDAMED
    FDA Recall Terminated

    Gyroscan ACS-NT with software versions R6x, R7x, R8x

    Recall: Z-1227-03 · Initiated November 21, 2002

    Recall

    Recall Number
    Z-1227-03
    Event Number
    26580
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2002
    Posted
    September 12, 2003
    Terminated
    January 13, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Gyroscan ACS-NT with software versions R6x, R7x, R8x

    Reason

    Patient burns from cables near or in contact with the patient during use

    Action

    On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.

    Distribution

    The firm distributed units to hospitals and medical centers throughout the U.S.

    Quantity

    435 total devices