Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error
Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. 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. The hazard is a software error preventing a specific remote control function, which is a functional defect but does not explicitly report injuries, hospitalizations, or structural failures in the source text.
Plain-English summary
Natus Medical Incorporated is recalling 928 units of EPWorks software versions prior to 6.0. This software is used in the Xltek Protektor Stimulator for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The product was 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 prevents the intended control of the waveform group during remote monitoring.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. Users of the affected software should refer to the manufacturer for further instructions on remediation or replacement.
The recalled product
- Product
- EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
- Manufacturer
- Natus Medical Incorporated
- Category
- Medical Device — Software
- Hazard
- Affected units
- 928
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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