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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 H48see related information
Date Initiated by FirmJuly 17, 2009
Date PostedSeptember 22, 2009
Recall Status1 Terminated 3 on November 27, 2010
Recall NumberZ-2231-2009
Recall Event ID 53045
510(K)NumberK071873 
Product Classification radiation therapy treatment planning system - Product Code MUJ
ProductVarian 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
ActionVarian 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 Commerce1
DistributionProduct was distributed to one user in Texas
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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