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Medical Devices Sector
قطاع الأجهزة الطبية
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ational
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enter for
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edical
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evices
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eporting
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NCMDR Recall
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Reference Number:
mdprc 096 07 14 000
Date submitted:
7/23/2014
Manufacturer:
Radiometer Medical
Device Type:
Anti-Virus Scan Tool
Description:
IVD, Analyzers
Medical Device Identifier:
Analyzer : ABL800FLEX and basic
Analyzer PC Configuration : DMS910 only ( hence not MB662 )
Analyzer : ABL90FLEX
Analyzer PC Configuration : UIM2743 and UIM910
Analyzer : AQT90FLEX
Analyzer PC Configuration : UIM2743 and UIM910
Reason of Field Safety Corrective Action:
Release of Anti-Virus Scan Tool for Field Service Engineers
Remedy Action:
The manufacturer recommends using the tool in the following situations:
- It is suspected that analyzer may be infected by virus
- Upon customer request
Athorized Representative/Importer/Distributor:
Salehiya Trading Est., (011) 2628939
Report Source:
NCMDR
Source Ref. Number:
CBD13AC8BE35C
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Radiometer Medical.pdf
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