BEUDAMED
    FDA Enforcement Class II Terminated

    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    Recall: Z-0142-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0142-2022
    Event ID
    88691
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 27, 2021
    Initiation Date
    November 11, 2020
    Classification Date
    October 19, 2021
    Termination Date
    June 30, 2023
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    Description

    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    Reason

    A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

    Code Info

    Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003

    Distribution

    US Nationwide distribution in the states of NV, AR MN.

    Quantity

    3 units