Company: Natus Medical Incorporated
Date of Enforcement Report 2/18/2015
Class lI:
PRODUCT
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The 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.
Recall Number Z-1067-2015
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.
RECALLING FIRM/MANUFACTURER
Natus Medical Incorporated, Oakville, ON, Canada on 1/2/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
248 units
DISTRIBUTION
Nationwid.
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