Recall Z-2763-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.
| Date | Jul 8, 2011 (initiated May 17, 2011) |
| Status | Terminated |
| Reason | An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265. ***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.*** |
| Quantity | 357 |
| Distribution | Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan Jordan, Kuwait, Malaysia, Morocco, Netherlands, Oman, Pakistan, P |
| 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 |