FDA Device recall Z-1407-2013
Natus neurology Dantec KEYPOINT.NET 2.20
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Natus neurology Dantec KEYPOINT.NET 2.20 by Alpine Biomed Aps, citing alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1407-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-09 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alpine Biomed Aps |
| Distribution | US |
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
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Identifiers
| code_info | SERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 3028…SERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 30286 30288 30323 30192 30214 30207 30325 30106 30168 21971 21972 30075 30212 21760 2717 30293 30365 36002 30193 36121 21962 36124 30364 35089 30045 35101 36090 21677 30362 35244 35209 36091 35297 36089 35032 35304 30167 30290 30110 30111 36012 30382 30410 30411 30412 30419 36107 36113 30407 35245 35293 35312 35181 35254 30315 30318 30384 35178 35173 35144 36186 36178 36199 2730 36125 36123 36132 30380 30428 20945 21249 21398 21580 21892 22120 30149 4268 20661 20704 20646 4140 4035 35190 30314 30328 30313 30327 30348 30401 30400 20322 21278 21272 21273 21678 21898 21747 21750 21823 21983 21741 21662 21989 22185 21821 22018 22017 22027 21826 21656 30124 30128 30130 30122 30032 30267 30268 30084 30022 30257 3637 4012 1956 20742 20737 20878 21581 2158 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.