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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 026 05 13 000
Alpine Biomed ApS
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
The user is requested to update the Keypoint.NET Software version 2.20 to version 2.21
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Code Information- Alpine Biomed ApS .pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.