Recall Z-2559-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
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 t
| Date | Jun 14, 2011 (initiated Jun 12, 2009) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |