Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031
FDA device recall Z-1407-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Alpine Biomed Aps
- 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.
- Action taken
- 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 required to complete these actions, please contact Technical Support Engineer Michael Jensen via e-mail michael.jensen@natus.com, alternatively QA/RA Engineer Michael Jacobsen by e-mail michael.jakobsen@natus.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GWF
- Quantity affected
- 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, T
- Date initiated
- 2013-04-09
- Date posted
- 2013-05-25
- Date terminated
- 2014-01-06
- Location
- Skovlunde, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DANTEC KEYPOINT (K944547) | Mckenna & Cuneo | 1995-09-19 |