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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 30, 2020
Date Posted June 05, 2020
Recall Status1 Terminated 3 on August 04, 2021
Recall Number Z-2289-2020
Recall Event ID 85651
510(K)Number K192482  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: 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 Serial numbers 600001 - 600043
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
Manufacturer Reason
for Recall		 potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified the service engineers of the issue and the risk to health (exposure to legionella) by email on 04/30/2020. The firm followed with a letter disseminated on 05/12/2020 to customers and service engineers which discussed the hazard and Elekta's updated preventative maintenance.
Quantity in Commerce 32 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, 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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