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 155 03 18 000
Date submitted: 3/28/2018
Manufacturer:Sekisui Diagnostics
Device Type:CP3000 System
Description:Automated Coagulation System
Medical Device Identifier:CP3000 Automated Coagulation System
Reason of Field Safety Corrective Action:SEKISUI MEDICAL CO., LTD. (SEKISUI) has become aware of several issues with the CP3000. The details of each and their impact are listed in the attached FSN
Remedy Action:The attached letter from Sekisui Medical provides information on immediate actions to be taken when using the CP3000 until software upgrades and any associated user manual updates are available.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:67DDCE18C52EF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Sekisui.pdf