BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0201-2014 · Initiated October 28, 2013

    Recall

    Recall Number
    Z-0201-2014
    Event Number
    66725
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 28, 2013
    Posted
    November 13, 2013
    Terminated
    December 24, 2014
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    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.

    Action

    Toshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information.

    Distribution

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

    Quantity

    18 units