Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured b
FDA device recall Z-0855-2009 · posted 2009-01-15 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- When using the multiple static segment option, the device may alter dose delivery.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 64 units
- Distribution
- Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
- Date initiated
- 2008-10-02
- Date posted
- 2009-01-15
- Date terminated
- 2010-11-27
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873) | Varian Medical Systems, Inc. | 2007-08-09 |