Class 2 Device Recall Linear Accelerator

• Date Initiated by Firm: April 19, 2012
• Date Posted: May 23, 2012
• Recall Status: Terminated on October 06, 2014
• Recall Number: Z-1651-2012
• Recall Event ID: 61812
• 510(K)Number: K082122
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: MLCi/MCLi2. Radiation therapy.
• Code Information: MRT 2424/MRT 14401
• 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: The Y2 diaphragm block was found loose.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
• Quantity in Commerce: 386
• Distribution: Nationwide Distribution including Puerto Rico.
• 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 = IYE