BEUDAMED
    FDA Recall Terminated

    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

    Recall: Z-0131-2021 · Initiated September 8, 2020

    Recall

    Recall Number
    Z-0131-2021
    Event Number
    86452
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    OUO
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 8, 2020
    Terminated
    April 28, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

    Reason

    Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

    Action

    On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.