• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Unity

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Elekta Unitysee related information
Date Initiated by FirmApril 03, 2019
Date PostedMay 08, 2019
Recall Status1 Terminated 3 on May 01, 2023
Recall NumberZ-1297-2019
Recall Event ID 82537
510(K)NumberK182076 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductElekta 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
ActionElekta 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 Commerce9 devices
DistributionWorldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
-
-