BEUDAMED
    FDA Enforcement Class II Terminated

    Infant Warmer System (IWS)

    Recall: Z-1015-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1015-2017
    Event ID
    75210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2017
    Initiation Date
    August 4, 2016
    Classification Date
    January 11, 2017
    Termination Date
    July 12, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Infant Warmer System (IWS)

    Reason

    GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

    Code Info

    Medical device listing number: D103053, D103054, D103056, D103057, D183529

    Distribution

    This product has been distributed domestically and internationally .

    Quantity

    32,073 (US = 24,361; OUS = 7,712)