Recall Z-1957-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.
| Date | Apr 12, 2011 (initiated Feb 7, 2011) |
| Status | Terminated |
| Reason | An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation. |
| Root cause | Software design |
| Action | Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected customers on February 7, 2011. |
| Quantity | 421 |
| 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 |