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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Unity

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  Class 2 Device Recall Elekta Unity see related information
Date Initiated by Firm June 24, 2019
Date Posted July 16, 2019
Recall Status1 Terminated 3 on April 01, 2021
Recall Number Z-1980-2019
Recall Event ID 83158
510(K)Number K182076  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Unity, Image-Guided Radiation Therapy System

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Code Information UDI/GTIN: 5060081071321 Installed product: UNITY SYSTEM/13553-006/600003 UNITY SYSTEM/10817-011/600010 UNITY SYSTEM/12473-020/600020 UNITY SYSTEM/12274-017/600012 UNITY SYSTEM/10562-011/600016 UNITY SYSTEM/10719-T03001/600013 UNITY SYSTEM/30004070-001/600023 UNITY SYSTEM/10420-AVL-U/600008 UNITY SYSTEM/11014-UMCU-U/600007 UNITY SYSTEM/10157-006/600014 UNITY SYSTEM/11611-40/600011 UNITY SYSTEM/11489-21/600009  
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Alejandra Carrillo
404-202-4333
Manufacturer Reason
for Recall		 The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
FDA Determined
Cause 2		 Software design
Action The firm, Elekta, disseminated their "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" by email on 06/24/2019 to its customers. The notices identified the problem, provided recommended actions, and requested the notice be placed in a place accessible to all users. Customers were also instructed to complete and return the Acknowledgement Form. A software update will be provided once available. If you have any questions, contact the Post Market Surveillance Specialist by email: Elekta_Global_PMS@elekta.com.
Quantity in Commerce 12 units
Distribution US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.
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 Limited
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