BEUDAMED
    FDA Enforcement Class II Terminated

    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

    Recall: Z-0201-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0201-2014
    Event ID
    66725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 28, 2013
    Classification Date
    November 12, 2013
    Termination Date
    December 24, 2014
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    Description

    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

    Reason

    Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.

    Code Info

    Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.

    Distribution

    USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.

    Quantity

    18 units