BEUDAMED
    FDA Recall Terminated

    Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.

    Recall: Z-1865-2011 · Initiated February 3, 2011

    Recall

    Recall Number
    Z-1865-2011
    Event Number
    57890
    Firm
    Xoft Inc.
    FEI Number
    3005594788
    Product Code
    IXI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 3, 2011
    Posted
    April 1, 2011
    Terminated
    June 8, 2011
    Address
    345 Potrero Avenue, Sunnyvale, CA, 94085

    Description

    Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.

    Reason

    Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.

    Action

    Xoft, Inc. sent an Urgent Field Removal Action letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and return all units and lots of Flexishield Mini Catalog Number: F5300 in their inventory. Customers were instructed to fill out the attached form and fax to 866-222-3404, then call Customers Service toll free directly at 877-963-8327 to make arrangements to return the product and receive a credit if applicable. Customers were asked to complete and return the form even if they did not have any units to return. For questions regarding this recall call 408-419-2300.

    Distribution

    Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI.

    Quantity

    165 units