SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCAR Recall

Back

Reference Number:	mdprc 103 06 14 000
Date submitted:	6/25/2014

Manufacturer:	GE Healthcare
Device Type:	CARESCAPE Monitor B850, B650 or B450
Description:	Patient Monitor
Medical Device Identifier:	The issue described above may occur in CARESCAPE B850, B650 and B450 monitors with V2 software versions.
Reason of Field Safety Corrective Action:	GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450.
Remedy Action:	GE Healthcare will provide a software solution at no charge to correct this issue. Until the correction is applied, all potential users should be aware of this safety notification and the recommended safety instructions in the attached file.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh (011) 4600530
Report Source:	NCAR
Source Ref. Number:	SA-2014-06-12-002
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	FMI_36103-36104_MS_English_Master_UMDC_Customer_Letter_KSA Localized.pdf

View History