FDA Medical Device Recalls (openFDA)
Xoft Inc.: Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
- Recall number
- Z-1865-2011
- Recalling firm
- Xoft Inc.
- Product
- Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
- Status
- Terminated
- Initiated
- 2011-02-03
- Posted
- 2011-04-01
- Terminated
- 2011-06-08
- 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.
- Root cause
- 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
- 165 units
- Distribution
- Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI.
- Lot, serial or model codes
- Model Number F5300; Lot numbers: 800218, 800239, 800240, 800321, 800334 and 800335.
- 510(k) numbers
- ["K090417"]
- PMA numbers
- not on file
- Product code
- IXI
- Firm FEI
- 3005594788
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28