Recall Z-2562-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. 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 form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring m
| Date | Jun 14, 2011 (initiated Nov 9, 2010) |
| Status | Terminated |
| Reason | Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment. |
| Root cause | Software design |
| Action | Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO. Customers were instructed to contact their local customer support office with any questions. |
| Quantity | 155 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Sin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |