Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Us
FDA device recall Z-2780-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.
- Action taken
- Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 10,097***12-12-12 AMENDED TO: 10664 units***
- Distribution
- Worldwide distribution: Nationwide (USA) and the country of Canada.
- Date initiated
- 2011-05-13
- Date posted
- 2011-07-11
- Date terminated
- 2014-08-15
- 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 |