Recall Z-1399-06 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system.
| Date | Aug 10, 2006 (initiated May 1, 2006) |
| Status | Terminated |
| Reason | Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters. |
| Root cause | Other |
| Action | The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only. |
| Quantity | 13 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912555 | GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER Rts Technology, Inc., Aug 2, 1991 |