Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Ecli
FDA device recall Z-0455-2011 · posted 2010-11-24 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record.
- Action taken
- On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 2417 units***12-20-12 AMENDED TO: 49 units***
- Distribution
- Nationwide and Worldwide
- Date initiated
- 2010-05-13
- Date posted
- 2010-11-24
- Date terminated
- 2012-02-24
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873) | Varian Medical Systems, Inc. | 2007-08-09 |
| VARIAN ORIGAMI, VERSION 1.0 (K932501) | Varian Assoc., Inc. | 1994-09-23 |