Recall Z-0164-2009 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing ir
| Date | Oct 22, 2008 (initiated Jun 2, 2008) |
| Status | Terminated |
| Reason | A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect. |
| Root cause | Software design |
| Action | Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees. |
| Quantity | 18 |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |