BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS ORT100 Table, Part Number 110470-000

    Recall: Z-0975-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0975-2018
    Event ID
    79360
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    February 20, 2018
    Classification Date
    March 13, 2018
    Termination Date
    August 27, 2019
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS ORT100 Table, Part Number 110470-000

    Reason

    The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.

    Code Info

    Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886

    Distribution

    US, Canada, Australia, China, Qatar

    Quantity

    15 tables