Recall Z-3194-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Varian Medical Systems, Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
| Date | Sep 14, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system. |
| Root cause | Pending |
| Action | Urgent Medical Device Correction/Field Safety Notification letters were sent to all US consignees by Certified Mail on July 21, 2011., as well as Varian Sales, Marketing and Service Organizations. Varian International Customer Support managers will notify international customers by appropriate methods. The letter informed customers of the issue and the corrective action steps. Letters request that all appropriate personnel working in the radiotherapy department be notified of the contents of the letter. A new release version is being created to correct the issue. All sites will be notified |
| Quantity | 1125 |
| Distribution | Worldwide Distribution -- USA, China, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guadeloupe, Ireland, Italy, Latvia, Lithuania, Martinique, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom, Singapore, Algeria, Bang |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091132 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Jun 17, 2009 |