Recall Z-0187-2013 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
| Date | Nov 1, 2012 (initiated Sep 24, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | "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. |
| Quantity | 205 |
| Distribution | Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093527 | ARIA RADIATION ONCOLOGY WITH MIRS Varian Medical Systems, Inc., Dec 15, 2009 |