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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 March 12, 2019
Create Date April 08, 2019
Recall Status1 Open3, Classified
Recall Number Z-1109-2019
Recall Event ID 82384
510(K)Number K182076  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Unity, Image-Guided Radiation Therapy System

Product Usage:
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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Code Information Unity Systems: 13553-006/600003, 13371-002/600021, 10817-011/600010, 10562-011/600016, 10719-T03001/600013, 30004070-001/600023, 10420-AVL-U/600008, 11014-UMCU-U/600007, 10157-006/600014, 11611-40/600011, 30001461-J001/600002, 11489-21/600009,    
Recalling Firm/
Manufacturer		 Elekta Limited
Linac House
Fleming Way
Crawley United Kingdom
Manufacturer Reason
for Recall		 Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
FDA Determined
Cause 2		 Software design
Action The firm issued a field safety notice on 03/12/2019 by email. The notice explained the issue and cautioned the consignee to select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Quantity in Commerce 12 units
Distribution Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
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