Recall Z-1407-2013 ยท GWF Stimulator, Electrical, Evoked Response
Alpine Biomed Aps
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,
| Date | May 25, 2013 (initiated Apr 9, 2013) |
| Status | Terminated |
| Reason | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug. |
| Root cause | Software design |
| Action | Alpine Biomed ApS sent a Recall Notification/ Field Safety Notice dated April 8, 2013 to all affected customers via e-mail and courier. Alpine Biomed ApS advised their customers to upgrade all installations of Keypoint.NET v2.20 to Keypoint.NET v2.21. Alpine BioMed ApS has recommended that their customers complete and return the verification form to QA/RA Engineer Michael Jacobsen at e-mail michael.jakobsen@natus.com. These actions and the return of the verification form to Alpine Biomed ApS should be completed within 3 months of receipt of the recall notifications. If any assistance is re |
| Quantity | 871 licenses installed |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944547 | DANTEC KEYPOINT Mckenna & Cuneo, Sep 19, 1995 |