Recall Z-0855-2009 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Oncology Systems
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.
| Date | Jan 15, 2009 (initiated Oct 2, 2008) |
| Status | Terminated |
| Reason | When using the multiple static segment option, the device may alter dose delivery. |
| Root cause | Software design |
| Action | 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 Ins |
| Quantity | 64 units |
| Distribution | Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands. |
| 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 |