Recall Z-0065-2014 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
| Date | Oct 24, 2013 (initiated Aug 9, 2013) |
| Status | Terminated |
| Reason | The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013. |
| Quantity | 3 sets |
| Distribution | Worldwide distribution: US (nationwide) distribution in CA and in the country of India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023220 | VARISOURCE BREAST TEMPLATE SYSTEM Varian Medical Systems, Oct 25, 2002 |