Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 1
FDA device recall Z-0552-2014 · posted 2013-12-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
- Action taken
- Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 6701
- Distribution
- Worldwide Distribution.
- Date initiated
- 2013-11-18
- Date posted
- 2013-12-20
- Date terminated
- 2015-03-13
- 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 |
|---|---|---|
| HIGH ENERGY LINEAR ACCELERATOR (K131807) | Varian Medical Systems, Inc. | 2013-10-11 |
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |