BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    Recall: Z-0428-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0428-2013
    Event ID
    63500
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovative Magnetic Resonance Imaging Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    October 19, 2012
    Classification Date
    November 21, 2012
    Termination Date
    December 11, 2012
    Address
    78 Innovation Drive, N/A, Winnipeg, Manitoba, N/A, Canada

    Description

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    Reason

    IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.

    Code Info

    10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513

    Distribution

    Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.

    Quantity

    23