Recall Z-1809-2009 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is 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 device from commencing irradiation
| Date | Aug 27, 2009 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager. |
| Quantity | 1,587 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |