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U.S. Department of Health and Human Services

Class 1 Device Recall Axxent Flexishield Mini

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  Class 1 Device Recall Axxent Flexishield Mini see related information
Date Initiated by Firm February 03, 2011
Date Posted April 01, 2011
Recall Status1 Terminated 3 on June 08, 2011
Recall Number Z-1865-2011
Recall Event ID 57890
510(K)Number K090417  
Product Classification Beam Blocks for Radiation Therapy - Product Code IXI
Product Axxent Flexishield Mini

To shape the beam from a low energy radiation therapy source up to 50kVp.
Code Information Model Number F5300; Lot numbers: 800218, 800239, 800240, 800321, 800334 and 800335.
Recalling Firm/
Manufacturer		 Xoft Inc.
345 Potrero Avenue
Sunnyvale CA 94085
For Additional Information Contact Steve Lin
408-419-2300
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 165 units
Distribution Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IXI and Original Applicant = XOFT, INC.
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