BEUDAMED
    FDA Recall Terminated

    TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.

    Recall: Z-1665-2011 · Initiated July 22, 2010

    Recall

    Recall Number
    Z-1665-2011
    Event Number
    56407
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 22, 2010
    Posted
    March 16, 2011
    Terminated
    April 5, 2011
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.

    Reason

    Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.

    Action

    The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to [email protected]. If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.

    Distribution

    Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.

    Quantity

    43 units