Recall Z-1067-2015— Natus Medical Incorporated
Class II · Terminated
Class II FDA medical device recall by Natus Medical Incorporated, initiated 2015-01-02, terminated 2017-03-22. It names one FDA 510(k) clearance: K093304. 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.. 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
- Natus Medical Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-02
- Terminated
- 2017-03-22
- Firm location
- Oakville, Ontario, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.