Recall Z-0295-2012 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
| Date | Nov 30, 2011 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave. |
| Root cause | Process control |
| Action | Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact informa |
| Quantity | 653 parts |
| Distribution | Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South C |
| 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 |