BEUDAMED
    FDA Recall Open, Classified

    Canon Aquilion Prime, Model TSX-303A

    Recall: Z-1723-2020 · Initiated March 25, 2019

    Recall

    Recall Number
    Z-1723-2020
    Event Number
    84954
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 25, 2019
    Posted
    April 10, 2020
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    Description

    Canon Aquilion Prime, Model TSX-303A

    Reason

    Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

    Action

    Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail.

    Distribution

    Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.

    Quantity

    10 devices