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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 035 11 18 000
Date submitted: 11/12/2018
Manufacturer:Abbott Diagnostic International Ltd
Device Type:G-Series, E-Series and BCM SCC RAM Inspection and Installation
Description:BCM SCC RAM
Medical Device Identifier:m2000rt System
m2000sp G-Series System
m2000sp E-Series System
Reason of Field Safety Corrective Action:Some BCM SCCs with Part Number 01L67-003 or 01L67-004 have a shortage of RAM. To make sure that every BCM has the correct memory configuration, this TSB provides instructions to inspect the quantity of RAM on SCCs and install additional RAM if needed.
Remedy Action:Please follow the instructions in attachment.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:52EED8BB1E2F1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott_.pdf