Natus neurology Dantec KEYPOINT — Class II medical device recall Z-1407-2013
Terminated recall by Alpine Biomed Aps, reported 2013-06-05, distributed nationwide. Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a
| Recall number | Z-1407-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alpine Biomed Aps, Skovlunde, N/A, Denmark |
| Recall initiated | 2013-04-09 |
| Classified | 2013-05-25 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BG, CH, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, ID, IL, IN, IR, IT, KR, NL, NO, PL, PT, RU, SA, SE, SG, SK, TH, TN, TR |
| Quantity | 871 licenses |
| Reason classes | software |
| Serial numbers | 1956, 2006, 20178, 20322, 20410, 20646, 20661, 20673, 20704, 20737, 20742, 20746, 2078, 20794, 20799, 20807, 20820, 2086, 20860, 20870, 20875, 20876, 20878, 20902, 20909 and 475 more |
| Model numbers | 9031A0031, 9031A0032, 9031A0063, 9031A006401, 9031A006402, 9031A006403, 9031A006405, 9031A006406, 9031A006501, 9031A006502, 9031A006503, 9031A006506, 9031A051306, 9031A070101, 9031A070102, 9031A070103, 9031A070105, 9031A070106, 9031A0701BV, 9033A0044, 9033A004606, 9033A004701, 9033A004706, 9033A0072, 9033A007301 and 27 more |
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, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 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.
Reason for recall
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1407-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.