Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x)
FDA device recall Z-1412-2010 · posted 2010-04-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.
- Action taken
- Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 3177 unit
- Distribution
- Nationwide distribution and Mexico.
- Date initiated
- 2009-12-09
- Date posted
- 2010-04-20
- Date terminated
- 2012-02-24
- 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 |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K073020) | Varian Medical Systems, Inc. | 2007-12-19 |