Natus Medical Incorporated recalls EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), ele…

Recall date

January 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1067-2015

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.