Class 2 Device Recall PrecisePLAN Treatment Planning System

• Date Initiated by Firm: January 28, 2008
• Date Posted: March 02, 2011
• Recall Status: Terminated 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/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 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: Other
• 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