Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.

The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle.

The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 24, 2011, to all affected users. The letter described the product, problem and actions to be taken. The customers were instructed to IMMEDIATELY inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle on the wedge tray; if any wedge is identified with mismatched labeling follow the written instructions provided in the letter; always measure wedge data at installation of new or replacement wedges; verify all treatment accessories of "matched" linear accelerators, and please advise the appropriate personnel working in your Radiotherapy Department of the content of this letter. Varian has enhanced their manufacturing quality control process to further ensure correct labeling of wedges. Also, Varian will replace any wedge that is identified as mislabeled, at the request of the customer. If you require further clarification, please feel free to contact your local Varian Customer Support Service Manager at: 1-888-VARIAN5 (888-827-4265) for USA and Canada; +14 41 749 8844 Europe; North American: [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].