BEUDAMED
    FDA Recall Terminated

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    Recall: Z-3000-2011 · Initiated July 13, 2011

    Recall

    Recall Number
    Z-3000-2011
    Event Number
    59404
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 13, 2011
    Posted
    August 11, 2011
    Terminated
    June 20, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    Reason

    Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to return all affected product to Varian Brachy Therapy by using the contact information provided in the letter. Replacement product will be provided free of charge to the customers. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    437 - all sizes