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 029 03 11 000
Date submitted:	3/7/2011

Manufacturer:	GE Healthcare
Device Type:	Advantage Workstation Reporting Tool, X-ray system
Description:	X-ray system, computed tomography, application program software
Medical Device Identifier:	All Reporting Tool versions 2.5 or earlier on Advantage Workstation
Reason of Field Safety Corrective Action:	It has been discovered that when editing multiple reports of one or more patients in Reporting Tool, a special editing workflow can result in a report where some edited data from one patient/exam is saved into the report of another patient/exam. This even raises a safety issue due to a potential patients data mismatch concern.
Remedy Action:	Open only one patient report at a time when editing a report in Reporting tool. GE Healthcare will correct all affected systems by providing a software upgrade 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:	47E50F7D80238
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	Manufacturer letter.pdf

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