Recall Z-1067-2015 ยท GWE Stimulator, Photic, Evoked Response
Natus Medical Incorporated
EPWorks 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.
| 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 | 248 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093304 | PROTEKTOR 32 Natus Medical, Inc., Aug 11, 2010 |