Recall Z-2599-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: 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 informa
| Date | Jun 20, 2011 (initiated Feb 6, 2009) |
| Status | Terminated |
| Reason | Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to |
| Root cause | Software design |
| Action | Elekta CMS Software sent an "ADVISORY NOTICE" dated February 6, 2009 to its affected customers. The notice identified the product, the problem, and the actions to be taken. Customers were informed that the workaround method available is to (edit the MLC pattern using the aperture first and the individual MLC leaf edits second). The firm states that this issue will be resolved in Focal version 4.50.00 and above. A "User Notice" will be sent to all users still using the affected software notifying them of the updated software available to correct the problem. If you have any questions, please |
| Quantity | 760 |
| Distribution | Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, Franc |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |