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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 017 09 18 000
Date submitted: 9/9/2018
Manufacturer:GE Healthcare
Device Type:CARESCAPE B450, B650, and B850 (Bx50) monitors
Medical Device Identifier:All CARESCAPE Monitor B450, CARESCAPE Monitor B650, and CARESCAPE Monitor B850
Reason of Field Safety Corrective Action:May restart due to network overload situation caused by network misconfiguration
Remedy Action:GE Healthcare will provide revised network installation and user instructions documentation at no cost to you.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:3B6C4450941CF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare-B450.pdf