BEUDAMED
    FDA Recall Terminated

    Ohmeda Giraffe SPOT PT Lite Phototherapy System

    Recall: Z-0160-06 · Initiated August 5, 2005

    Recall

    Recall Number
    Z-0160-06
    Event Number
    32920
    Firm
    Datex Ohmeda, Inc. dba GE Healthcare
    FEI Number
    1121732
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 5, 2005
    Posted
    November 18, 2005
    Terminated
    October 24, 2007
    Address
    8880 Gorman Rd, Laurel, MD, 20723-5800

    Description

    Ohmeda Giraffe SPOT PT Lite Phototherapy System

    Reason

    Phototherapy medical device may lose its position and can cause a safety hazard to the patient.

    Action

    The firm notified consignees by letter on 08/05/2005 and advised of field correction of the devices in 2 phases. The letter is lot specific and provides for an interim workaround and includes an adhesive sticker and instructions for tagging the device with a warning statement containing restriction for use : 'This phototherapy light should ONLY be used on patients in closed incubators.' The letter further advises of firm''s plan to provide free, mandatory repair at a later date, pending hardware solution.

    Distribution

    Product was distributed to medical facilities in the US and international subsidiaries and distributors.

    Quantity

    2701 devices