Recall Z-1268-06 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy.
| Date | Jul 27, 2006 (initiated May 1, 2006) |
| Status | Terminated |
| Reason | Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually. |
| Root cause | Other |
| Action | The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response |
| Quantity | 254 total units |
| Distribution | Nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983436 | GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM Gammamed USA, Oct 29, 1998 |