Devices

Device Recall Protektor 32 (EPWorks software)

Model / Serial
EPWorks Software Versions prior to 6.0
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
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.
Manufacturer
Natus Medical Incorporated
1 Event
- Recall of Device Recall Protektor 32 (EPWorks software)

Manufacturer

Natus Medical Incorporated

Manufacturer Address
Natus Medical Incorporated, 2568 Bristol Circle, Oakville Canada Ontario
Manufacturer Parent Company (2017)
Natus Medical Incorporated
Source
USFDA

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