BEUDAMED
    FDA Recall Terminated

    GE Discovery MR950 MRI system

    Recall: Z-1395-2015 · Initiated October 24, 2014

    Recall

    Recall Number
    Z-1395-2015
    Event Number
    70701
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    IWE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 24, 2014
    Posted
    May 1, 2015
    Terminated
    May 6, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Discovery MR950 MRI system

    Reason

    The alignment lasers are missing the labels required by radiation safety regulations.

    Action

    GE Planned action(s) to repair defect or to bring product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 5 units consists of the following: 1. New labels will be mailed to all purchasers, with instructions to apply the label in the appropriate location on the unit, or a GE field engineer will be sent to each user site to complete the correction. 2. All mailings and service calls will be made at no cost to the purchaser. 3. The corrections will be completed by August 1, 2015. If you have any questions, please contact your local Service Representative or call 1 (800) 437-1171.

    Distribution

    US Distribution to the state of CA., and Internationally to Italy and Japan.

    Quantity

    5 units (2 in US)