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U.S. Department of Health and Human Services

Class 2 Device Recall Protektor 32 (EPWorks software)

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 Class 2 Device Recall Protektor 32 (EPWorks software)see related information
Date Initiated by FirmJanuary 02, 2015
Date PostedFebruary 09, 2015
Recall Status1 Terminated 3 on March 22, 2017
Recall NumberZ-1067-2015
Recall Event ID 70157
510(K)NumberK093304 
Product Classification Stimulator, photic, evoked response - Product Code GWE
ProductEPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.
Code Information EPWorks Software Versions prior to 6.0
Recalling Firm/
Manufacturer		 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
ActionNatus 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 Commerce248 units
DistributionUS Nationwide Distribution
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 = GWE
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