FDA Recall
Terminated
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
Recall: Z-0911-2011
·
Initiated August 17, 0010
Recall
- Recall Number
- Z-0911-2011
- Event Number
- 56772
- Firm
- Varian Medical Systems, Palo Alto, CA 911 Hansen Way Palo Alto CA 94304-1028
- FEI Number
- 2916710
- Product Code
- MUJ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 17, 0010
- Posted
- January 18, 2011
- Terminated
- July 21, 2011
Description
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
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.
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.
Distribution
Worldwide Distribution.
Quantity
7019