BEUDAMED
    FDA Enforcement Class II Terminated

    Giraffe Incubator with installed Servo Oxygen module. Infant incubator.

    Recall: Z-2236-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2236-2020
    Event ID
    85643
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    April 28, 2020
    Classification Date
    June 15, 2020
    Termination Date
    September 23, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Giraffe Incubator with installed Servo Oxygen module. Infant incubator.

    Reason

    Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

    Code Info

    Giraffe Incubator: serial numbers HDGA through HDGQ; Servo Oxygen Board spare part kit: 6600-0233-850; Servo Oxygen upgrade kits: 6600-0678-800, 6600-0678-801, 6600-0678-802, 6600-0678-803, 66000849-800, 6600-0849-801, 6600-0849-802, 6600-0849-803, 6600-0866-800, 6600-0866-801, 6600-0867800, 6600-0867-801, M1142293 or M1142295.

    Distribution

    Worldwide Distribution. US nationwide including US Virgin Islands, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Hong Kong, India, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latam, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, OMAN, State of Palestine, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen

    Quantity

    5,883 units total