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Terminated

Theratron 1000 Cobalt Radiotherapy

FDA Recall Z-1180-06 · Posted 2006-06-27

Recalling FirmMDS Canada Inc. DBA MDS Nordion
Recall StatusTerminated
Product CodeIWB
Date Initiated2004-07-08
Date Terminated2006-06-27
Product Quantity16 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.

K001006THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADEMds Nordion · 2000-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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