BEUDAMED
    FDA Recall 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 · Initiated May 18, 2015

    Recall

    Recall Number
    Z-1849-2015
    Event Number
    71451
    Firm
    Varian Medical Systems Inc
    FEI Number
    3011400544
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    May 18, 2015
    Posted
    June 26, 2015
    Terminated
    September 12, 2016
    Address
    501 Locust Ave, Charlottesville, VA, 22902-4869

    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).

    Action

    All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.

    Distribution

    Worldwide Distribution.

    Quantity

    55