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U.S. Department of Health and Human Services

Class 2 Device Recall Optical Guidance Platform

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  Class 2 Device Recall Optical Guidance Platform see related information
Date Initiated by Firm January 26, 2009
Date Posted January 10, 2011
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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