Recall Z-0607-2013 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
| Date | Dec 20, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve. |
| Root cause | Device Design |
| Action | The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE" letter dated September 28, 2012 to all affected consignees/Customers. The letter identified the affected product, description of problem and recommended user actions to be taken. The consignees/customers were instructed to immediately remove all affected guiding tubes from clinical use, and sequester the components for pending return to Varian Brachy Therapy. Consignees/Customers were requested to complete the attached proof of notification form and return it to Varian Medical Systems. |
| Quantity | 15 units |
| Distribution | Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand. |
| 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 |