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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 Unitysee related information
Date Initiated by FirmJanuary 04, 2019
Create DateJanuary 09, 2019
Recall Status1 Completed
Recall NumberZ-0706-2019
Recall Event ID 81886
510(K)NumberK182076 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductElekta Unity
Code Information Serial Numbers: 1536549, 1536549 
Recalling Firm/
Manufacturer		 Elekta Limited
Linac House
Fleming Way
Crawley United Kingdom
Manufacturer Reason
for Recall		In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.
Quantity in Commerce2 units
DistributionTX and WI, Germany, Denmark, Netherlands, United Kingdom
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.
510(K) Database510(K)s with Product Code = IYE
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