Recall Z-1385-2012 ยท KXK Source, Brachytherapy, Radionuclide
Varian Medical Systems, Inc.
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.
| Date | Apr 10, 2012 (initiated Jan 25, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 1377 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030534 | VARISEED 7.1 Varian Medical Systems, May 21, 2003 |