Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, 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 algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.

An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse.

Varian Medical Systems sent a Urgent Medical Device Correction letter dated December 12, 2011, to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to pay careful attention to any warnings displayed regarding the Virtual Collimator Jaws when the plan is calculated. If the warning indicates that the Virtual Collimator Jaws are inside the MLC aperture, do not proceed with the calculation. Varian is continuing to evaluate possible technical solutions for this issue. Special Instructions for customers outside the USA and Canada: In order to satisfy regulatory requirements, we request that you complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. "We sincerely apologize for any inconvenience and thank you in advance for your cooperation." Please call for USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844.