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U.S. Department of Health and Human Services

Class 2 Device Recall Agility

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  Class 2 Device Recall Agility see related information
Date Initiated by Firm July 27, 2012
Date Posted September 10, 2012
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-2340-2012
Recall Event ID 62915
510(K)Number K121328  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Multileaf Collimator

To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Code Information 152599 and 152678
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-300-9725
Manufacturer Reason
for Recall		 Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
FDA Determined
Cause 2		 Error in labeling
Action ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725.
Quantity in Commerce 2
Distribution Nationwide Distribution including DC & MD
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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