FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: Elekta XiO Radiation Treatment Planning System
- Recall number
- Z-1655-2010
- Recalling firm
- Computerized Medical Systems Inc
- Product
- Elekta XiO Radiation Treatment Planning System
- Status
- Terminated
- Initiated
- 2010-04-15
- Posted
- 2010-05-26
- Terminated
- 2012-06-07
- Reason
- Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening
- Root cause
- Software design
- Action
- Elekta issued an undated "Important Safety Notice" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.
- Quantity
- The release is being used by 34 customers that also have an Elekta linear accelerator
- Distribution
- Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
- Lot, serial or model codes
- Release 4.50.00 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