Recall Z-2592-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above 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
| Date | Jun 20, 2011 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient. |
| Root cause | Software design |
| Action | Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround. |
| Quantity | 308 |
| Distribution | Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |