Z-1068-2015Class II

EPWorks software used in the Xltek Protektor Stimulator

Name: Z-1068-2015 EPWorks software used in the Xltek Protektor Stimulator
Creator: Natus Medical Incorporated
Published: 2015-01-02
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2015-01-02 / Terminated / root cause: software

FDA source

Natus Medical Incorporated began a recall of EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought... on 2015-01-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1068-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-02
Posted: 2015-02-09
Terminated: 2017-03-22
Recalling firm: Natus Medical Incorporated
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.
Product code: GWF Stimulator, Electrical, Evoked Response
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.
Root cause tag: software
FDA root cause: 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 [email protected] or [email protected].
Quantity in commerce: 928 units
Distribution: US Nationwide Distribution
Product codes and lots: EPWorks Software Versions prior to 6.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1068-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1067-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09
Z-1068-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09

Product code GWF

K040358Class IIXltek Protektor Stimulator, Models 10247 & 10248Excel Tech. , Ltd. / cleared 2004-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)