BEUDAMED
    FDA Recall Terminated

    TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.

    Recall: Z-2468-2012 · Initiated May 13, 2008

    Recall

    Recall Number
    Z-2468-2012
    Event Number
    63166
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 13, 2008
    Posted
    September 27, 2012
    Terminated
    September 27, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.

    Reason

    The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

    Action

    Toshiba American Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. customers: The firm advised customers to take the following temporary measures to avoid issues until a corrective action has been taken: I. In SureStart: " Perform scanning with Observation Direction set to VFF when the Patient Insertion Direction and Observation direction are FF. " Perform scanning with the Observation direction set to VFH when the Patient Insertion Direction and Observation Direction are HF. 2. When acquiring images for 4D perfusion analysis: " Perform scanning with the Scan Direction set to OUT when the Patient Insertion Direction and Scan Direction are HF. Perform scanning with the scan direction set to IN when the Patient Insertion Direction and Scan Direction are FF. Contact the firm at (800) 421-1968 for questions regarding this issue.

    Distribution

    Nationwide distribution: USA including states of: MA, MD, and NV.

    Quantity

    3 units