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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 April 03, 2019
Date Posted May 08, 2019
Recall Status1 Terminated 3 on May 01, 2023
Recall Number Z-1297-2019
Recall Event ID 82537
510(K)Number K182076  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Unity systems

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 Product Code: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, 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/11611-40/600011, UNITY SYSTEM/11489-21/600009;   UDI: 1536549, 1536549  
Recalling Firm/
Manufacturer		 Elekta Limited
Linac House
Fleming Way
Crawley United Kingdom
Manufacturer Reason
for Recall		 There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
FDA Determined
Cause 2		 Labeling design
Action Elekta notified customers on about 04/03/2019 via email with "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Instructions included to ensure all staff working with Elekta Unity are aware of the issue and recall information and post the recall notice in a place accessible to all users, e.g. Instructions for use, until the recall is closed. Additionally customer were asked to complete and return the Acknowledgement Form.
Quantity in Commerce 9 devices
Distribution Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
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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