Theratron 780E Cobalt Radiotherapy
FDA Recall Z-1179-06 · Posted 2006-06-27
Recalling FirmMDS Canada Inc. DBA MDS Nordion
Recall StatusTerminated
Product CodeIWB
Date Initiated2004-07-08
Date Terminated2006-06-27
Product Quantity78 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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, Algeria, Portugal, Poland, Iran, China, Cuba, Belgium, Hungary, Egypt, Italy, Vietnam, Sri Lanka, and Costa Rica.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.