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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 059 06 12 000
Date submitted: 6/12/2012
Manufacturer:GE Healthcare
Device Type:Monitor, CARESCAPE TM Monitor B850
Description:Monitor
Medical Device Identifier:CARESCAPE TM Monitor B850.
Reason of Field Safety Corrective Action:(1) CARESCAPE Monitor B850 uDOM failure. It is possible that the CARESCAPE Monitor B850 may enter into a constant boot loop causing monitor to reboot continuously (2) CARESCAPE Monitor B850 unstable USB communication (3) CARESCAPE Monitor B850 reboots due to an X server freeze. (Find attached file for more details)
Remedy Action:GE Healthcare will provide a software and hardware correction at no charge once it is available. GE will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh, (01) 4600530
Report Source:NCMDR
Source Ref. Number:F22C697FB62BC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare (1).pdf