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.
Recall
- Recall Number
- Z-1068-2015
- Event Number
- 70157
- Firm
- Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario
- FEI Number
- 3002809369
- Product Code
- GWF
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 2, 2015
- Posted
- February 9, 2015
- Terminated
- March 22, 2017
Description
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.
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.
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].
US Nationwide Distribution
928 units