BEUDAMED
    FDA Recall Terminated

    Toshiba Aquilion CT System TSX-301B

    Recall: Z-0015-2016 · Initiated May 8, 2015

    Recall

    Recall Number
    Z-0015-2016
    Event Number
    71923
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 8, 2015
    Posted
    October 9, 2015
    Terminated
    October 26, 2016
    Address
    2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba Aquilion CT System TSX-301B

    Reason

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

    Action

    Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.

    Distribution

    US Distribution including Puerto Rico

    Quantity

    459