BEUDAMED
    FDA Recall Open, Classified

    Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

    Recall: Z-2357-2026 · Initiated May 8, 2026

    Recall

    Recall Number
    Z-2357-2026
    Event Number
    99036
    Firm
    Datex-Ohmeda Inc
    FEI Number
    3036470679
    Product Code
    BTM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 8, 2026
    Posted
    June 18, 2026
    Address
    3114 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

    Reason

    Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

    Action

    Firm began notifying customers on 5/8/2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were instructed to identify affected devices by following instructions provided in the letter. Devices with affected blenders should be removed from patient use, and the customer should contact a GE HealthCare Service Representative.

    Distribution

    Pending

    Quantity

    550 (367 US; 183 OUS)