Recall Z-2081-2008 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000.
| Date | Sep 16, 2008 (initiated Mar 12, 2008) |
| Status | Terminated |
| Reason | Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment. |
| Root cause | 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 |
| Quantity | 120 units |
| Distribution | The medical devices were distributed to radiation oncology facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR Mick Radio-Nuclear Instruments, Inc., Apr 3, 2003 |