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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 Device Recall PrecisePLAN Treatment Planning System see related information
Date Initiated by Firm January 28, 2008
Date Posted March 02, 2011
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-1476-2011
Recall Event ID 57692
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/
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
Manufacturer Reason
for Recall
PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
FDA Determined
Cause 2
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 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) Database 510(K)s with Product Code = MUJ and Original Applicant = PRECISION THERAPY INTL., INC.