Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8
FDA device recall Z-0911-2011 · posted 2011-01-18 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Palo Alto, CA
- Reason for recall
- 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 taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 7019
- Distribution
- Worldwide Distribution.
- Date initiated
- 0010-08-17
- Date posted
- 2011-01-18
- Date terminated
- 2011-07-21
- 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 |