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U.S. Department of Health and Human Services

Class 2 Device Recall Theratron 1000

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 Class 2 Device Recall Theratron 1000see related information
Date Initiated by FirmJuly 08, 2004
Date PostedJune 27, 2006
Recall Status1 Terminated 3 on June 27, 2006
Recall NumberZ-1180-06
Recall Event ID 35617
510(K)NumberK001006 
Product Classification System, Radiation Therapy, Radionuclide - Product Code IWB
ProductTheratron 1000 Cobalt Radiotherapy
Code Information Model Theratron 1000
Recalling Firm/
Manufacturer		 MDS Canada Inc. DBA MDS Nordion
447 March Road
Kanata Canada
For Additional Information ContactRoss Kachaniwsky
613-592-3400 Ext. 2234
Manufacturer 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 Determined
Cause 2		Other
ActionA 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 Commerce16 units
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IWB
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