X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
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