BEUDAMED
    FDA Enforcement Class II Terminated

    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

    Recall: Z-1101-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1101-2013
    Event ID
    64670
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    October 15, 2012
    Classification Date
    April 11, 2013
    Termination Date
    November 6, 2013
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    Description

    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

    Reason

    It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni

    Code Info

    Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.

    Distribution

    USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.

    Quantity

    27 units