Class 2 Device Recall CSeries Clinac, Trilogy and Novalis Tx

• Date Initiated by Firm: October 08, 2009
• Date Posted: January 18, 2011
• Recall Status: Terminated on February 24, 2012
• Recall Number: Z-0910-2011
• Recall Event ID: 53778
• 510(K)Number: K904364m K913119 K070094
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. ; Device 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 inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
• Code Information: to be added.
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Dave Hall; 650-424-5731
• Manufacturer Reason for Recall: Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.
• Quantity in Commerce: 5208 units
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = VARIAN ASSOC., INC.; 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.