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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 067 06 18 000
Date submitted: 6/17/2018
Manufacturer:GE Healthcare
Device Type:TwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant.
Description:GE Healthcare MRI systems Software Version
Medical Device Identifier:This correction applies to some units of the following GE Healthcare MRI system types: TwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant.
Reason of Field Safety Corrective Action:It has come to our attention that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. If the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Remedy Action:GE Healthcare will inspect all affected systems and ensure the proper software version is installed. This will be performed at no cost to you. GE Healthcare will check systems remotely (on-line) where possible, and will visit your site if a remote check is not possible.

GE Healthcare will advise you after your software version has been inspected and inform you if any correction is needed. If a correction is needed, a service representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:261CF65FA0237
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare - MRI.pdf