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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48

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  Class 2 Device Recall Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48 see related information
Date Initiated by Firm July 17, 2009
Date Posted September 22, 2009
Recall Status1 Terminated 3 on November 27, 2010
Recall Number Z-2231-2009
Recall Event ID 53045
510(K)Number K071873  
Product Classification radiation therapy treatment planning system - Product Code MUJ
Product Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.
Code Information Model number H48, code number H484023.
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		 Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
FDA Determined
Cause 2		 Software design
Action Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.
Quantity in Commerce 1
Distribution Product was distributed to one user in Texas
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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