Theratron Elite 80 Cobalt Radiotherapy
FDA device recall Z-1183-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- MDS Canada Inc. DBA MDS Nordion
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 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, P
- Date initiated
- 2004-07-08
- Date posted
- 2006-06-27
- Date terminated
- 2006-06-27
- Location
- Kanata, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERATRON ELITE (K983917) | Theratronics, Inc. | 1998-12-04 |