Recall Z-0932-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian Medial Systems, Palo Alto, CA Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
| Date | Jan 21, 2011 (initiated Dec 14, 2010) |
| Status | Terminated |
| Reason | Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present. |
| Root cause | Software design |
| Action | Urgent Medical Device Correction/Field Safety notification letters were distributed to all affected users, and to Varian Sales, Marketing and Service Organizations on December 14, 2010 by certified mail. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters described the issue and recommended user actions along with Varian's actions. Users are to use caution when acquiring actual couch positions for any plan. In addition, each plan should be reviewed for quality assurance purposes |
| Quantity | 4188 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081036 | 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) Varian Medical Systems, Inc., May 9, 2008 |