Class 2 Device Recall Varian

• Date Initiated by Firm: September 10, 2007
• Date Posted: February 14, 2008
• Recall Status: Terminated on November 27, 2010
• Recall Number: Z-0545-2008
• Recall Event ID: 45520
• 510(K)Number: K070094
• Product Classification: Linear Accelerator - Product Code IYE
• Product: Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system; Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC -- Stereotactic motion disable Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
• Code Information: The Serial Numbers: H180001, H180007, H180076, H180143, H180147, H180169, H180181, H180187, H180195, H180222, H180273, H180276, H180311, H180314, H180322, H180460, H180467, H180473, H180490, H180493, H180514, H180533, H180550, H180563, H180566, H180570, H180576, H180599, H180613, H180631, H180671, H180690, H180697, H180718, H180731, H180739, H180779, H180785, H180786, H180808, H180815, H180816, H180822, H180836, H180844, H180855, H180877, H180894, H181065, H180066, and H180769
• Recalling Firm/ Manufacturer: Varian Medical Systems Inc; 911 Hansen Way; Palo Alto CA 94304
• For Additional Information Contact: 650-424-5731
• Manufacturer Reason for Recall: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
• FDA Determined Cause: Labeling design
• Action: On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.
• Quantity in Commerce: 418 (total for Recalls Z-0544-0545-2008)
• Distribution: Worldwide- Canada, Mexico, and the USA
• 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