BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    Recall: Z-0144-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0144-2015
    Event ID
    69265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IMRIS Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    October 1, 2014
    Classification Date
    October 28, 2014
    Termination Date
    February 20, 2015
    Address
    5101 Shady Oak Rd S, N/A, Hopkins, MN, 55343-4100, United States

    Description

    IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    Reason

    One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.

    Code Info

    10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

    Distribution

    Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.

    Quantity

    14