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U.S. Department of Health and Human Services

Class 2 Device Recall Linear Accelerator

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  Class 2 Device Recall Linear Accelerator see related information
Date Initiated by Firm April 19, 2012
Date Posted May 23, 2012
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ELEKTA LTD.
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