BEUDAMED
    FDA Recall 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 · Initiated October 19, 2012

    Recall

    Recall Number
    Z-0428-2013
    Event Number
    63500
    Firm
    Innovative Magnetic Resonance Imaging Systems Inc.
    FEI Number
    3003807210
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 19, 2012
    Posted
    November 21, 2012
    Terminated
    December 11, 2012
    Address
    78 Innovation Drive, Winnipeg Canada Manitoba

    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.

    Action

    Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.

    Distribution

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

    Quantity

    23