Recall Z-1412-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Oncology Systems
Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.
| Date | Apr 20, 2010 (initiated Dec 9, 2009) |
| Status | Terminated |
| Reason | Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan. |
| Root cause | Software design |
| Action | Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue. |
| Quantity | 3177 unit |
| Distribution | Nationwide distribution and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073020 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Dec 19, 2007 |