Z-1183-06

Theratron Elite 80 Cobalt Radiotherapy

Name: Z-1183-06 Theratron Elite 80 Cobalt Radiotherapy
Creator: MDS Canada Inc. DBA MDS Nordion
Published: 2004-07-08
License: https://open.fda.gov/license/

Bwxt Medical Ltd. / initiated 2004-07-08 / Terminated

FDA source

MDS Canada Inc. DBA MDS Nordion began a recall of Theratron Elite 80 Cobalt Radiotherapy on 2004-07-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1183-06
Status: Terminated
Initiated: 2004-07-08
Posted: 2006-06-27
Terminated: 2006-06-27
Recalling firm: Bwxt Medical Ltd.
Product: Theratron Elite 80 Cobalt Radiotherapy
Product code: IWB System, Radiation Therapy, Radionuclide
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.
FDA 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 in commerce: 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, Algeria, Portugal, Poland, Iran, China, Cuba, Belgium, Hungary, Egypt, Italy, Vietnam, Sri Lanka, and Costa Rica.
Product codes and lots: Model Theratron Elite 80

Product code IWB

K983917Class IITheratron EliteTheratronics, Inc. / cleared 1998-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)