Recall Z-1183-06 ยท IWB System, Radiation Therapy, Radionuclide
MDS Canada Inc. DBA MDS Nordion
Theratron Elite 80 Cobalt Radiotherapy
| Date | Jun 27, 2006 (initiated Jul 8, 2004) |
| Status | Terminated |
| Reason | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. |
| Root cause | Other |
| Action | A User Bulletin (CUB-2004-01dated 7/5/04) was issued to affected users on 8/24/04 and 8/31/04. The bulletin provided 2 options for corrective action. |
| Quantity | 17 units |
| Distribution | The products were shipped to medical facilities in FL and KS. The product was also shipped to Kuwait, Spain, Honduras, Romania, France, Grrece, Bangladesh, Germany, Nepal, Canada, England, Thailand, Phillippines, Mexico, Columbia, India, Switzerland, Syria, Trinidad & Tobago, Ireland, Turkey, Algeri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983917 | THERATRON ELITE Theratronics, Inc., Dec 4, 1998 |