FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
- Recall number
- Z-2559-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
- Status
- Terminated
- Initiated
- 2009-06-12
- Posted
- 2011-06-14
- Terminated
- 2014-04-09
- Reason
- Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.
- Root cause
- Software design
- Action
- Computerized Medical System sent a CUSTOMER ADVISORY dated June 12, 2009, to all affected users. This advisory identified the product, the problem, and the action needed to be taken by the customer. There were no patients mistreated as a result of this issue The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403 ) 830-8023
- Quantity
- 462
- Distribution
- Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, Nicaragua, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, and Venezuela.
- Lot, serial or model codes
- Focal Release 4.34.00 through 4.50.00
- 510(k) numbers
- ["K013112"]
- 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