Recall Z-3055-2011 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc. Oncology Systems
Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
| Date | Aug 22, 2011 (initiated Jul 13, 2011) |
| Status | Terminated |
| Reason | Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice. |
| Quantity | 1019 total |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Varian Medical Systems, Dec 24, 2003 |