Recall Z-1717-2009 ยท KXK Source, Brachytherapy, Radionuclide
Source Production & Equipment Inc
M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
| Date | Mar 3, 2008 |
| Status | Terminated |
| Reason | Radioactive source broke during use. |
| Root cause | Other |
| Action | Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units. |
| Quantity | 3 units |
| Distribution | Nationwide Distribution -- GA, NV and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE Source Production & Equipment Co., Inc., Apr 19, 2006 |