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Medical Devices Sector
قطاع الأجهزة الطبية
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NCAR Recall
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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
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