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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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