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Terminated

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.

FDA Recall Z-1407-2013 · Posted 2013-05-25

Recalling FirmAlpine Biomed Aps
Recall StatusTerminated
Product CodeGWF
Date Initiated2013-04-09
Date Terminated2014-01-06
Product Quantity871 licenses installed

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.

Firm 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 [email protected]. 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 [email protected], alternatively QA/RA Engineer Michael Jacobsen by e-mail [email protected].

Root Cause

Software design

Distribution Pattern

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, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944547DANTEC KEYPOINTMckenna & Cuneo · 1995-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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