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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 090 10 18 000
Date submitted: 10/18/2018
Manufacturer:Randox Laboratories Ltd.
Device Type:RX Monaco
Description:Clinical chemistry analyzer
Medical Device Identifier:Catalogue Number: RX5000
Reason of Field Safety Corrective Action:The RX Monaco software update version UI 3.017.001 is now available to download from the designated Randox FTP site.
Remedy Action:Discuss content of this notice with your Medical Director Read the FSU and Technical Bulletin provided Implement software changes and update the parameters as supplied
Athorized Representative/Importer/Distributor:Bio Standards
Report Source:NCMDR
Source Ref. Number:2B7F2D86481A5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Randox Laboratories Ltd..pdf