Recall Z-0911-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Palo Alto, CA
Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System
| Date | Jan 18, 2011 (initiated Aug 17, 10) |
| Status | Terminated |
| Reason | Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose. |
| Root cause | Software design |
| Action | Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected users on August 6, 2010. Letters were also sent to Varian Sales, Marketing and Service organizations to inform them of the recall. |
| Quantity | 7019 |
| Distribution | Worldwide Distribution. |
| 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 |