ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a tre
FDA device recall Z-0187-2013 · posted 2012-11-01 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
- Action taken
- "Urgent Medical Device Correction/ Urgent Field Safety Notice" letters were sent on September 24, 2012 by Certified Mail with return receipt to all affected users. The problem was described and recommended user actions were provided. The notification letters were to also be distributed to Varian Sales, Marketing, and Service organizations. US customers may contact the Varian help desk at 1-(888) 827-4265.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 205
- Distribution
- Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
- Date initiated
- 2012-09-24
- Date posted
- 2012-11-01
- Date terminated
- 2013-12-05
- 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 |
|---|---|---|
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |