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.

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.

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 in accordance to set departmental or organizational policies. The firm updated the procedure and enclosed a copy with the letter. It was also posted to the customer support site. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.