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U.S. Department of Health and Human Services

Class 2 Device Recall PrecisePLAN Treatment Planning System

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 Class 2 Recall
PrecisePLAN Treatment Planning System
see related information
Date Posted March 02, 2011
Recall Status1 Terminated on April 21, 2011
Recall Number Z-1476-2011
Recall Event ID 57692
Premarket Notification
510(K) Number
K022411 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
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Recalling Firm/
Manufacturer
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross, Georgia 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer Reason
for Recall
PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .
Quantity in Commerce 277 units
Distribution Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = PRECISION THERAPY INTL., INC.
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