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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 122 03 11 000
Date submitted: 3/30/2011
Manufacturer:GE Healthcare
Device Type:LightSpeed Computed Tomography X-ray System
Description:The GE LightSpeed VCT Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
Medical Device Identifier:LightSpeed VCT Computed Tomography X-ray systems with software version 10 MW 06.5 distributed from June 2010 to August 2010
Reason of Field Safety Corrective Action:During a helical or scout scan, the table could stop while X-ray continues, due to a specific table communication fault.
Remedy Action:GE Healthcare will provide a software update for all affected systems to address the issue
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh (01) 4600530
Report Source:NCMDR
Source Ref. Number:CE15CDCADC356
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:No Attachments