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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 December 18, 2019
Create Date June 30, 2020
Recall Status1 Terminated 3 on June 15, 2021
Recall Number Z-2473-2020
Recall Event ID 85620
510(K)Number K192482  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Unity, Image-Guided Radiation Therapy System
Code Information Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
Manufacturer Reason
for Recall		 There have been reports of excessive heating in the MRL Gradient Connection Module.
FDA Determined
Cause 2		 Process control
Action Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorrect connection material has been completed to ensure that continued use of the Elekta Unity system is acceptable, however, it remained that further actions can be taken to reduce the risk.
Quantity in Commerce 21 devices
Distribution Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
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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