Class 2 Device Recall Optical Guidance Platform

• Date Initiated by Firm: January 26, 2009
• Date Posted: January 10, 2011
• Recall Status: Terminated on February 24, 2012
• Recall Number: Z-0888-2011
• Recall Event ID: 51217
• 510(K)Number: K071360
• Product Classification: accessory to radiation therapy machine - Product Code IYE
• Product: Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).
• Code Information: Codes HZ5071, HZ59014 and HZ59017.
• FEI Number: 2916710
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: 650-424-5731
• Manufacturer Reason for Recall: Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
• FDA Determined Cause: Device Design
• Action: Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations.
• Quantity in Commerce: 3 units
• Distribution: Product was distributed to 3 consignees in Florida and Wisconsin.
• 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