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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 060 06 12 000
MRI, Signa and Discovery
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.
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.
GE Healthcare, Riyadh, (01) 4600530
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
GE Healthcare (2).pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.