BEUDAMED
    FDA Recall Terminated

    Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators

    Recall: Z-1047-05 · Initiated April 25, 2005

    Recall

    Recall Number
    Z-1047-05
    Event Number
    31665
    Firm
    Ohmeda Medical, A division of Datex-Ohmeda, Inc.
    FEI Number
    1121732
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 25, 2005
    Posted
    July 28, 2005
    Terminated
    January 11, 2007
    Address
    8880 Gorman Rd, Laurel, MD, 20723-5800

    Description

    Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators

    Reason

    Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.

    Action

    Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.

    Distribution

    The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.

    Quantity

    1674 devices