BEUDAMED
    FDA Enforcement Class II 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 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0877-2020
    Event ID
    84655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    December 23, 2019
    Classification Date
    January 28, 2020
    Termination Date
    December 11, 2020
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    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.

    Code Info

    Mfg. Lot or Serial # System ID 22D-4-0868 901BMHCRITMR HDGOC1900010SC 209521SGMR HDGOC1900015SC 4577711MR11 002776WHF 954916MR1 022D-4-1175 808243MR 857 LONGWOOD30MR2 00000290815MR0 508580BMR3 002801WHF 734246MR 002930WHF 845279MR 00000269040MR2 412749MR1 022D-4-1125 801RIVMR2 HDGOC1900003SC 206386SMR H05114 4815915MR11 00000277443MR8 304526SMR1 To be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408

    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