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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 016 09 12 000
Date submitted:
9/2/2012
Manufacturer:
Radiometer America Inc
Device Type:
IVD, ABL80 CO-OX analyzer
Description:
IVD, analyzer
Medical Device Identifier:
REF 933-257 Software upgrade to v1.60.
Reason of Field Safety Corrective Action:
A software upgrade for the ABL80 CO-OX analyzer is now available. This software version includes minor software enhancements and bug fixes only.
Remedy Action:
For specific customers considering any of the software bug fixes to be important we recommend that the ABL80 CO-OX analyzer software is upgraded to V1.60. For all other customers we recommend to wait for the next software release.
Athorized Representative/Importer/Distributor:
Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:
NCMDR
Source Ref. Number:
B7783094E92DC
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Radiometer America Inc.pdf
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