BEUDAMED
    FDA Recall Terminated

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    Recall: Z-0281-06 · Initiated October 12, 2005

    Recall

    Recall Number
    Z-0281-06
    Event Number
    33997
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2005
    Posted
    December 14, 2005
    Terminated
    July 12, 2007
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    Reason

    To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.

    Action

    Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.

    Distribution

    Nationwide

    Quantity

    65