Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.

Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated November 28, 2011 ***Expanded to include product #2 on December 16, 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 to be taken by the customer. Customers were instructed to establish a comprehensive quality assurance program before beginning treatments for the day, quality assurance tests must be performed. Additionally, any discrepancies in imaging field sizes vs planned field size should be brought to the attention of the medical physicist for investigation before treatment continues. Customers were asked to complete the attached Proof of Notification or Receipt Verification Card once they have read the document and return it to Varian Medical Systems. For question regarding this recall: USA and Canada 1-888-827-4265 Europe +41 41 749 8844