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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 026 05 13 000
Date submitted: 5/8/2013
Manufacturer:Alpine Biomed ApS
Device Type:Keypoint.NET, Electromyograph
Description:Keypoint.NET, Electromyograph
Medical Device Identifier:Software version: version 2.20 Serial no.: see attached
Reason of Field Safety Corrective Action:The manufacturer received a complaint about a report generator error in the KP NET SW ver. 2.20. Investigation showed that there was a software bug which caused inconsistent sorting between muscle and related scorings in a table when this is printed out. Screen appearance is ok
Remedy Action:The user is requested to update the Keypoint.NET Software version 2.20 to version 2.21
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:DK-2013-04-25-027
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Code Information- Alpine Biomed ApS .pdf