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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: EPWorks Software Versions prior to 6.0
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Natus Medical Incorporated
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
EPWorks Software Versions prior to 6.0
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1067-2015
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