BEUDAMED
    FDA Recall Terminated

    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.

    Recall: Z-2688-2016 · Initiated May 6, 2016

    Recall

    Recall Number
    Z-2688-2016
    Event Number
    74064
    Firm
    Invivo Corporation
    FEI Number
    1000113495
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 6, 2016
    Terminated
    August 21, 2019
    Address
    3545 SW 47th Ave, Gainesville, FL, 32608-7691

    Description

    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.

    Reason

    A diode was inadvertently not assembled into the system, which may result in coil overheating

    Distribution

    WI

    Quantity

    3