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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 036 04 18 000
Date submitted: 4/8/2018
Manufacturer:GE Healthcare
Device Type:Discovery IGS 730/740, Innova IGS 620/630/520/530/540 systems
Description:Radiographic/Fluoroscopic Systems, Angiography/Interventional
Medical Device Identifier:Discovery IGS 730/740 and Innova IGS 620/630/520/530/540 systems.
00197VAS02, 082416040090, 082416090100, 082416100144, 082416100152, 082416120092, 082416160068, 082416240024, 082416270031, 083016246178617, 083172440628, 16055VAS01, 253874IR, 304256INGS, 401BIPLANE1, 410337CATH3, 414649IGS5, 414649IGS6, 423493CATH1, 478765NSP, 479441CV4, 505841CATH3, 603433IGS520, 603663DIGS, 712279DIS, 716845DISC, 724658IGS530, 815759MCHCAR1, 856342IGS, 856342INIGS, 901516INIGS, 904BHHCHY, 956632IGS630, M2505310, YV4502
Reason of Field Safety Corrective Action:The Discovery IGS and Innova IGS systems may experience X-ray abort errors during a real-time interventional procedure. This issue could potentially happen before or during fluoroscopic use and could result in the loss of imaging capability.
Remedy Action: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:C7688445D32CB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf