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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 Recall
Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48
see related information
Date Posted September 22, 2009
Recall Status1 Open
Recall Number Z-2231-2009
Recall Event ID 53045
Premarket Notification
510(K) Number
K071873 
Product Classification System,Planning,Radiation Therapy Treatment - 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, California 94304-1028
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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