SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 060 06 12 000
Date submitted:	6/12/2012

Manufacturer:	GE Healthcare
Device Type:	MRI, Signa and Discovery
Description:	MRI, scanner, Full Body
Medical Device Identifier:	Discovery MR450, Optima MR450w (with and without GEM), Discovery MR750, Optima MR360, Brivo MR355, Signa HDx, Signa HDxt, Signa Vibrant, Signa HDi, Signa HDe 1.5T, Ovation HD, and Profile HD
Reason of Field Safety Corrective Action:	The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.
Remedy Action:	GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh, (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	696DB56569259
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare (2).pdf

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