Recall Z-1068-2015 ยท GWF Stimulator, Electrical, Evoked Response
Natus Medical Incorporated
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.
| Date | Feb 9, 2015 (initiated Jan 2, 2015) |
| Status | Terminated |
| Reason | 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 | 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_Servi |
| Quantity | 928 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 Excel Tech. , Ltd., Aug 6, 2004 |