Recall Z-1199-2012 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in
| Date | Mar 12, 2012 (initiated Jan 5, 2012) |
| Status | Terminated |
| Reason | Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy depart |
| Quantity | 122 total units |
| Distribution | Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071467 | VARISOURCE IX HDR AFTERLOADER Varian Medical Systems, Inc., Jul 16, 2007 |