BEUDAMED
    FDA Recall Terminated

    Giraffe OmniBed infant warmer

    Recall: Z-0538-2020 · Initiated October 11, 2019

    Recall

    Recall Number
    Z-0538-2020
    Event Number
    84077
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    FMT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 11, 2019
    Posted
    December 3, 2019
    Terminated
    August 15, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Giraffe OmniBed infant warmer

    Reason

    Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

    Action

    The firm disseminated its notices by letter beginning on 10/11/2019. The notices identified the following safety issues: - The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched. - The portholes also can look closed when not latched. - If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched. The product may continue to be used following specific safety instructions outlined in the notice. On/about 11/8/2019, the firm issued an "Amended - Urgent Medical Device Recall" letter that supplemented the previous notification to provide additional safety instructions and materials (poster regarding risk of patient fall, user manual addendum, and labeling, including safety labels). Update 6/3/2021: In the event a new consignee was identified, GE Healthcare has sent the original letter.

    Distribution

    worldwide

    Quantity

    23,693 units