Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
Recall
- Recall Number
- Z-0855-2009
- Event Number
- 50143
- Firm
- Varian Medical Systems Oncology Systems
- FEI Number
- 2916710
- Product Code
- MUJ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 2, 2008
- Posted
- January 15, 2009
- Terminated
- November 27, 2010
- Address
- 911 Hansen Way, Palo Alto, CA, 94304-1028
Description
Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
When using the multiple static segment option, the device may alter dose delivery.
An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of "Eclipse External Beam Planning Instruction for Use", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.
Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
64 units