Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error
Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software error that prevents a specific function without reporting any injuries, illnesses, or adverse health consequences. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Natus Medical Incorporated is recalling EPWorks software versions prior to 6.0 used in the Protektor 32 system. The recall involves 248 units distributed nationwide in the United States.
The recall is due to a software error that occurs when using remote monitoring. If a remote user attempts to stop the free run waveform group, the system displays a message stating that the user does not have sufficient privilege. This error prevents the intended function of stopping the waveform group during remote monitoring.
The Protektor 32 system uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG), and transcranial motor evoked potentials (TcMEP) stimulation techniques to help healthcare professionals assess a patient's neurological status during surgery. Users of the affected software versions should contact Natus Medical Incorporated for further instructions on resolving the issue.
The recalled product
- 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…
- Manufacturer
- Natus Medical Incorporated
- Hazard
- Affected units
- 248
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- EPWorks Software Versions prior to 6.0
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Natus Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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