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U.S. Department of Health and Human Services

Class 2 Device Recall BrachyVision Software, part of Eclipse TPS

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 Class 2 Recall
BrachyVision Software, part of Eclipse TPS
see related information
Date Posted August 31, 2011
Recall Status1 Terminated on November 25, 2011
Recall Number Z-3103-2011
Recall Event ID 59217
Premarket Notification
510(K) Number
K091492 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.
Code Information Versions 8.2, 8.5, 8.6 and 8.9
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville, Virginia 22903-4584
For Additional Information Contact Mark Kattmann
434-977-8495
Manufacturer Reason
for Recall
Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
FDA Determined
Cause 2
DESIGN: Software Design
Action Varian Medical Systems, Inc. sent a "Medical Device Recall" letter dated August 05, 2010 to all affected customers. The letter included description of product affected and problem. Customers were advised to review template files to ensure that there are no characters immediately after the string in the customized dose quality parameters. Device users were requested to return a response form. For information on this recall contact Varian Technical Support at (800) 360-7909.
Quantity in Commerce 1252 units
Distribution Worldwide and Nationwide Distribution.
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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