Recall Z-3105-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian Treatment version 6.6.5052. Varian Medical Systems, Palo Alto, Ca Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
| Date | Aug 31, 2011 (initiated Jul 20, 2011) |
| Status | Terminated |
| Reason | Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field. |
| Root cause | Other |
| Action | Varian Medical Systems sent out "Urgent Medical Device Correction/Urgent Field Safety Notice" letters dated July 20, 2011 to all affected customers. The letter identified product, problem and provided recommended user actions when setting up and running the system. It also asked customers to notify appropriate personal provided instructions. For information or questions on this recall please call Varian at (888) VARIAN5 (888- 827-4265). |
| Quantity | 118 |
| Distribution | Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093967 | VARIAN TREATMENT Varian Medical Systems, Inc., Jul 12, 2010 |