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 120 04 16 000
Date submitted:	4/26/2016

Manufacturer:	GE Healthcare
Device Type:	Discovery IGS 730 & Discovery IGS 740 systems .
Description:	X-ray system
Medical Device Identifier:	All Discovery IGS 730 & Discovery IGS 740 systems.
Reason of Field Safety Corrective Action:	The affected Discovery systems may experience multiple X-Ray abort errors during a real-time Interventional procedure. This issue could potentially happen before or during a fluoroscopic Interventional procedure.
Remedy Action:	You may continue to use the system. Before each use, have established procedures for handling patients in case of loss of fluoroscopic imaging during an exam as stated in your product labelling. Be sure the system is functional before each use. If the failure occurs during an interventional procedure or you experience repeated x-ray abort errors during the exam, follow your established procedures in the case of complete loss of fluoroscopic imaging. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	0A5AEB40CE25D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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