BEUDAMED
    FDA Recall Terminated

    Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

    Recall: Z-0479-2019 · Initiated September 25, 2018

    Recall

    Recall Number
    Z-0479-2019
    Event Number
    81224
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 25, 2018
    Terminated
    July 13, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

    Reason

    Potential electric leakage affecting the user.

    Action

    GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    1,724 devices total