BEUDAMED
    FDA Recall Terminated

    TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography

    Recall: Z-3198-2011 · Initiated June 22, 2011

    Recall

    Recall Number
    Z-3198-2011
    Event Number
    59690
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 22, 2011
    Posted
    September 13, 2011
    Terminated
    August 11, 2014
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography

    Reason

    Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr

    Action

    Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy. 2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy. 3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list. 4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility. Customers were asked to complete and return the attached form and fax it to 877-349-3054. For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.

    Distribution

    Nationwide Distribution

    Quantity

    155 units total