Recall Z-2231-2009 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Oncology Systems
Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.
| Date | Sep 22, 2009 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered. |
| Root cause | Software design |
| Action | Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned. |
| Quantity | 1 |
| Distribution | Product was distributed to one user in Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Aug 9, 2007 |