BEUDAMED
    FDA Enforcement Class II 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 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2688-2016
    Event ID
    74064
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invivo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 7, 2016
    Initiation Date
    May 6, 2016
    Classification Date
    August 30, 2016
    Termination Date
    August 21, 2019
    Address
    3545 SW 47th Ave, N/A, Gainesville, FL, 32608-7691, United States

    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

    Code Info

    Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

    Distribution

    WI

    Quantity

    3