BEUDAMED
    FDA Recall Terminated

    Infant Warmer System (IWS)

    Recall: Z-1015-2017 · Initiated August 4, 2016

    Recall

    Recall Number
    Z-1015-2017
    Event Number
    75210
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    FMT
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    August 4, 2016
    Terminated
    July 12, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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.

    Action

    This recall strategy includes the depth of the recall, plan for public warning and effectiveness check. The strategy outlined below addresses these elements for this particular recall. The plan for public warning is to contact all customers with potentially affected product by means of an Urgent Medical Device Correction letter. The letter will instruct customers that they can continue to use the device by following instructions on the Addendum to the Service Manual. The Service Manual Addendum provides instructions for checking and tightening the screws. In the US the letter will be sent by a traceable means [either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX]. This letter will be sent to: Nurse Manager, Labor & Delivery/NICU; Manager, Bio-Medical Engineering; and Director of Risk Management.

    Distribution

    This product has been distributed domestically and internationally .

    Quantity

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