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U.S. Department of Health and Human Services

Class 2 Device Recall Variseed 7.1

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  Class 2 Device Recall Variseed 7.1 see related information
Date Initiated by Firm January 25, 2012
Date Posted April 10, 2012
Recall Status1 Terminated 3 on November 07, 2012
Recall Number Z-1385-2012
Recall Event ID 61364
510(K)Number K030534  
Product Classification Source, brachytherapy, radionuclide - Product Code KXK
Product VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
Code Information device is not coded
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Mika Miettinen
650-424-6037
Manufacturer Reason
for Recall		 Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
FDA Determined
Cause 2		 Labeling design
Action Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.
Quantity in Commerce 1377 units
Distribution Worldwide Distribution
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 = KXK and Original Applicant = VARIAN MEDICAL SYSTEMS
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