Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
FDA Recall Z-1865-2011 · Posted 2011-04-01
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Recalling FirmXoft Inc.
Recall StatusTerminated
Product CodeIXI
Date Initiated2011-02-03
Date Terminated2011-06-08
Product Quantity165 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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