BEUDAMED
    FDA Enforcement Class II Terminated

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    Recall: Z-1849-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1849-2015
    Event ID
    71451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 8, 2015
    Initiation Date
    May 18, 2015
    Classification Date
    June 26, 2015
    Termination Date
    September 12, 2016
    Address
    501 Locust Ave, Charlottesville, VA, 22902-4869, United States

    Description

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    Reason

    After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).

    Code Info

    JAQ

    Distribution

    Worldwide Distribution.

    Quantity

    55