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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 Device Recall BrachyVision Software, part of Eclipse TPSsee related information
Date Initiated by FirmAugust 11, 2010
Date PostedAugust 31, 2011
Recall Status1 Terminated 3 on November 25, 2011
Recall NumberZ-3103-2011
Recall Event ID 59217
510(K)NumberK091492 
Product Classification Radiation Therapy Treatment Planning System, - Product Code MUJ
ProductBrachyVision, 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 VA 22903-4584
For Additional Information ContactMark 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		Software design
ActionVarian 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 Commerce1252 units
DistributionWorldwide and Nationwide Distribution.
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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