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Natus Medical Incorporated recalls EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP),
Recalled February 18, 2015 · FDA recall Z-1067-2015 · Natus Medical Incorporated
Hazard
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. · FDA Class II
Units
248 units
Sold at
US Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Natus Medical Incorporated
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →