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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Treatment Planning System

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  Class 2 Device Recall Eclipse Treatment Planning System see related information
Date Initiated by Firm December 09, 2009
Date Posted April 20, 2010
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1412-2010
Recall Event ID 54648
510(K)Number K073020  
Product Classification radiation treatment planning system - Product Code MUJ
Product Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.
Code Information v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x), with serial numbers starting with H48.
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 for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.
FDA Determined
Cause 2		 Software design
Action Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.
Quantity in Commerce 3177 unit
Distribution Nationwide distribution and Mexico.
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 = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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