BEUDAMED
    FDA Recall 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 · Initiated October 1, 2014

    Recall

    Recall Number
    Z-0144-2015
    Event Number
    69265
    Firm
    IMRIS Inc
    FEI Number
    3010326005
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    October 1, 2014
    Posted
    October 28, 2014
    Terminated
    February 20, 2015
    Address
    5101 Shady Oak Rd S, Hopkins, MN, 55343-4100

    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.

    Action

    Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.

    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