BEUDAMED
    FDA Recall Terminated

    Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.

    Recall: Z-3055-2011 · Initiated July 13, 2011

    Recall

    Recall Number
    Z-3055-2011
    Event Number
    59402
    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 22, 2011
    Terminated
    June 20, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.

    Reason

    Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" 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 locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.

    Distribution

    Worldwide Distribution

    Quantity

    1019 total