Recall Z-1905-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The 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. ARIA Radiation Oncology also stores the trea
| Date | Apr 7, 2011 (initiated Feb 18, 2011) |
| Status | Terminated |
| Reason | An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect. |
| Root cause | Other |
| Action | Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items. For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265. Europe +41 41 749 8844 |
| Quantity | 645 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, HOng Kong, Hungary, India, Indonesia, Iraq, Ireland, Isr |
| 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 |