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U.S. Department of Health and Human Services

Class 2 Device Recall VariSource CT/MR Ring & Tandem Applicator Set

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  Class 2 Device Recall VariSource CT/MR Ring & Tandem Applicator Set see related information
Date Initiated by Firm March 12, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on November 28, 2012
Recall Number Z-2081-2008
Recall Event ID 48219
510(K)Number K030110  
Product Classification remote-controlled radionuclide applicator system - Product Code JAQ
Product VariSource¿ CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000.
Code Information catalog # AL13017000, all lots
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Varian Brachytherapy
800-360-7909
Manufacturer Reason
for Recall		 Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.
FDA Determined
Cause 2		 Device Design
Action The firm notified medical device users by letter on 03/12/08. The notification provided updated instructions for use for the CT/MR Ring and Tandem Combination Applicator Set. Users were advised to characterize all ring applicators to develop an offset correction for each dwell position in order to construct a plan to deliver the dwell positions accurately and reliably. The characterization can be done by creating a set of autoradiographs with intended dwell positions and define treatment plan shifts in order to deliver dwell positions in intended locations. Users were advised that a subsequent set of verification autoradiographs should be made using the derived plan shifts to verify the corrected source positioning. The notification also advised that an individual ring's behavior can change over its duration of use and that periodic commissioning is dictated to ensure reproducibility and compensate for changes in the device over time. Users were instructed to inform all employees and extend the notice to any consignees. Users were requested complete and return the enclosed response form. If you have questions about this recall, send an email to brachyhelp@varian,com.
Quantity in Commerce 120 units
Distribution The medical devices were distributed to radiation oncology facilities nationwide.
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 = JAQ and Original Applicant = MICK RADIO-NUCLEAR INSTRUMENTS, INC.
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