FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
- Recall number
- Z-2577-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
- Status
- Terminated
- Initiated
- 2008-04-08
- Posted
- 2011-06-16
- Terminated
- 2014-04-08
- Reason
- XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.
- Root cause
- Software design
- Action
- The firm, CMS, Inc., sent a "XiO Customer Advisory" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given. If you have any questions, please call 408-380-8023.
- Quantity
- 75
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.
- Lot, serial or model codes
- XiO Release 4.0.0 through 4.40.00
- 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