VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- March 12, 2008
- Posted
- September 16, 2008
- Terminated
- November 28, 2012
- Recall Number
- Z-2081-2008
- Quantity
- 120 units
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.
Distribution
The medical devices were distributed to radiation oncology facilities nationwide.
Lot / Code Info
catalog # AL13017000, all lots
Root Cause
Device Design
Action Taken
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.