Device product
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.
Z-1067-2015
Product summary
- Event
- Event 70157
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248 units
- Official record key
device-enforcement:Z-1067-2015
Official wording
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.
Code information: EPWorks Software Versions prior to 6.0
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
Software error