BEUDAMED
    FDA Recall Terminated

    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    Recall: Z-0877-2020 · Initiated December 23, 2019

    Recall

    Recall Number
    Z-0877-2020
    Event Number
    84655
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 23, 2019
    Posted
    January 28, 2020
    Terminated
    December 11, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    Reason

    It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

    Action

    This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.

    Distribution

    Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    62 (30 US, 32 OUS) total devices