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U.S. Department of Health and Human Services

Class 2 Device Recall Xltek Protektor Stimulator (EPWorks software)

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  Class 2 Device Recall Xltek Protektor Stimulator (EPWorks software) see related information
Date Initiated by Firm January 02, 2015
Date Posted February 09, 2015
Recall Status1 Terminated 3 on March 22, 2017
Recall Number Z-1068-2015
Recall Event ID 70157
510(K)Number K040358  
Product Classification Stimulator, electrical, evoked response - Product Code GWF
Product EPWorks software used in the Xltek Protektor Stimulator

Product Usage:
Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Code Information EPWorks Software Versions prior to 6.0
Recalling Firm/
Natus Medical Incorporated
2568 Bristol Circle
Oakville Canada Ontario
Manufacturer Reason
for Recall
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
FDA Determined
Cause 2
Software design
Action Natus Medical Inc. DBA Excel-Tech Ltd (Xltek) issued medical device notification letters dated December 22, 2014 to their customers vial email and via courier service on January 2, 2015. Within the notice, customers are instructed are on to removal the previous installation and also on how to install the new program upgrade. Natus Medical Inc. has requested that the Previous Version Removed from Use Confirmation form be completed by each customer and returned. Customers who require assistance can contact Natus Technical service by calling 800-387-7516 or via email Oakville_Technical_Service@xltek.com or ots@natus.com.
Quantity in Commerce 928 units
Distribution US Nationwide 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 = GWF and Original Applicant = EXCEL TECH. LTD.