BEUDAMED
    FDA Enforcement Class II Ongoing

    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

    Recall: Z-1726-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1726-2020
    Event ID
    84954
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    March 25, 2019
    Classification Date
    April 16, 2020
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

    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.

    Code Info

    Canon Aquilion ONE GENESIS Edition, Whole-Body X-Ray CT Scanner, Model TSX-305A - Serial number 3LA1652001, 3LA17Y2020, 3LB1872025, 3LA1762010, 3LA1772012, 3LA1762009, 3LB1882026, 3LA1752007, 3LA1762008, 3LA1772013, 3LA1732006, 3LA1772015, 3LA1772014, 3LA16Y2003, 3LA1792017, 3LA1782016, 3LA1712005, 3LB1832021, 3LA16Z2004, 3LA17Y2019, 3LB1842022, 3LA1772011, 3LB1852024, 3LA17X2018, 3OB1852023, 6LB18Y2013, 6LB1892008, 6LB1862002, 6LB1882007, 6LB1852001, 6LB1892009, 6LB18Y2011, 6LB1872005, 6LB1872006, and 6OB1862003.

    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

    35 devices