Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect

The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION; URGENT FIELD SAFETY NOTICE" dated June 18, 2012, to all affected users. The notice described the product, problem and actions to be taken. Varian is developing a technical correction for this issue. The customers will be contacted by a Varian Customer Service representative when this correction is available to schedule its installation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. In USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844; email: [email protected] Email: North America: [email protected]; Australia/New Zealand: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected] and Latin America: [email protected]. Internet: Oncology systems customer site - www.myvarian.com and Varian Medical Systems public site - www.varian.com.