FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
- Recall number
- Z-2408-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
- Status
- Terminated
- Initiated
- 2010-09-10
- Posted
- 2011-06-03
- Terminated
- 2014-04-08
- Reason
- When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.
- Root cause
- Software design
- Action
- Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.
- Quantity
- 1377
- Distribution
- Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
- Lot, serial or model codes
- XiO Release 1.0.2 and above
- 510(k) numbers
- ["K092132"]
- PMA numbers
- not on file
- Product code
- muj
- Firm FEI
- 1937649
- Firm city
- Maryland Heights
- Firm state
- MO
- 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