BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    Recall: Z-1218-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1218-2018
    Event ID
    79366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    February 23, 2018
    Classification Date
    March 27, 2018
    Termination Date
    August 27, 2019
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    Reason

    The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.

    Code Info

    Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255

    Distribution

    US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia

    Quantity

    13 units