Class 2 Device Recall Clinac C series

• Date Initiated by Firm: June 06, 2006
• Date Posted: July 06, 2006
• Recall Status: Terminated on December 03, 2007
• Recall Number: Z-1206-06
• Recall Event ID: 35728
• 510(K)Number: K862645
• Product Classification: Accelerator, Linear, Medical - Product Code IYE
• Product: Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.
• Code Information: All lots
• FEI Number: 2916710
• Recalling Firm/ Manufacturer: Varian Medical Systems Inc; 911 Hansen Way; Palo Alto CA 94304
• Manufacturer Reason for Recall: Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
• FDA Determined Cause: Other
• Action: The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.
• Quantity in Commerce: 217 units
• Distribution: Worldwide
• 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