BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    Recall: Z-1264-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1264-2018
    Event ID
    79488
    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 28, 2018
    Termination Date
    September 12, 2019
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    Reason

    The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

    Code Info

    (a) 113821-000, Serial Numbers: 10006997, 10002220 (b) 113821-600, Serial Numbers: 10002692,10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005189, 10005190, 10006891, 10004997, 10004327 (d) 114148-600, Serial Numbers: 10005201, 10006891

    Distribution

    US, Canada, China, Australia, Sweden, Germany

    Quantity

    17 units