Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; 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.

An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.

The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 4, 2011, to its customers. ***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 letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Set the Planning Approved status in Eclipse (Eclipse displays both the Actual and Planned SSD values during plan approval) and verify both SSD values prior to approving the plan. 2)Verify the SSD values in the Eclipse Treatment Plan Report prior to approving the plan for treatment or proceeding with treatment delivery (this report lists both the Actual and Planned SSD values). 3) Prior to approving the plan in RT Chart, verify both the Actual and Planned SSD values in the Parameters Workspace by selecting Field Parameters>Geometry tab. 4) Prior to treatment, they should verify intended SSD values during independent MU calculation. 5)Re-familiarize themselves with the concepts of Actual SSD and Planned SSD by reviewing the listed information. Please advise the appropriate personnel working in your radiotherapy department of the content of this letter. Varian mitigated the product behavior in version 8.9. If you require further clarification, please feel free to contact the Varian Oncology Help Desk ; phone: USA and Canada - 1888-827-4265; Europe: +41 41 749 8844; email: North America: [email protected]; Australia/New Zealand: [email protected]; Europe: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected]; Latin America: [email protected]; Internet: Oncology Systems-www.myvarian.com; Varian Medical Systems -www.varian.com; or your local Varian Customer Support District or Regional Manager.