FDA Medical Device Recalls (openFDA)
MDS Canada Inc. DBA MDS Nordion: Theratron 780E Cobalt Radiotherapy
- Recall number
- Z-1179-06
- Recalling firm
- MDS Canada Inc. DBA MDS Nordion
- Product
- Theratron 780E Cobalt Radiotherapy
- Status
- Terminated
- Initiated
- 2004-07-08
- Posted
- 2006-06-27
- Terminated
- 2006-06-27
- 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
- 78 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.
- Lot, serial or model codes
- Model Theratron 780E
- 510(k) numbers
- ["K964606"]
- PMA numbers
- not on file
- Product code
- IWB
- Firm FEI
- 3001092088
- Firm city
- Kanata
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28