FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, Release 4.51.00.
- Recall number
- Z-1209-2010
- Recalling firm
- Computerized Medical Systems Inc
- Product
- XiO Radiation Treatment Planning System, Release 4.51.00.
- Status
- Terminated
- Initiated
- 2010-02-22
- Posted
- 2010-03-25
- Terminated
- 2011-08-24
- Reason
- Inconsistent MLC positions, dose, and monitor units
- Root cause
- Software design
- Action
- Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
- Quantity
- Planning system is loaded 25 in locations
- Distribution
- Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
- Lot, serial or model codes
- Release 4.51.00
- 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