BEUDAMED
    FDA Recall Completed

    SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

    Recall: Z-0137-2022 · Initiated August 26, 2021

    Recall

    Recall Number
    Z-0137-2022
    Event Number
    88665
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Completed
    Root Cause
    Software design
    Initiated
    August 26, 2021
    Posted
    October 16, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

    Reason

    Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

    Action

    GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.

    Distribution

    Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

    Quantity

    6 devices