The Recall Desk
ModerateFDA (Devices)·Z-1407-2013·Announced 2013-06-05

Alpine Biomed Recalls Natus Dantec KEYPOINT.NET Software Due to Bug

Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.

What this means for you

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 source text does not report any hospitalizations, injuries, or deaths, and the hazard is a software bug without specified severe physical consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software. The recall is being conducted due to the presence of a software bug in the product.

The affected software is installed on the Keypoint EMG System, which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles. A total of 871 licenses are installed.

The product was distributed worldwide, including in the United States and numerous international countries such as Germany, France, India, and Australia. The source text does not specify specific corrective actions for consumers or report any injuries or illnesses associated with the software bug.

The recalled product

Product
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A05
Manufacturer
Alpine Biomed Aps
Category
Medical Device — Software
Hazard
Affected units
871

Distribution

Distributed nationwide across the United States.

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