Recall Z-2125-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment.
| Date | May 2, 2011 (initiated Mar 9, 2011) |
| Status | Terminated |
| Reason | An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc. Oncology Systems sent Urgent Medical Device Correction Field Safety Notice letters on March 9, 2011, to all affected customers. ***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.*** The letters identifeid the product, the problem, and the action to be taken by the customer. Customers were instructed to: Manually enter the gantry angel 0.0 when the plan indicates angel 0.0. Manual entry is only allowed to one decimal place, so the range that triggers the issue cann |
| Quantity | 612 units |
| Distribution | Worldwide Distribution - USA including CA, DC, FL, GA, MD, MN, MS, NY, OH, and TN and the countries of Canada, Australia, Austria, Bahrain, Bagladesh, Belarus, Belgium, Brazil, Columbia, Costa Rica, Cypress, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Hon |
| 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 |