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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 030 10 15 000
Date submitted: 10/11/2015
Manufacturer:GE Healthcare
Device Type:Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer ..
Description:X-ray
Medical Device Identifier:Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher and Centricity Universal Viewer versions 6.0 and higher.
Reason of Field Safety Corrective Action:Inaccurate distance measurements with magnified projection X-ray images.
Remedy Action:GE Healthcare will correct all affected systems by providing a software update at no cost to you.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:369D82042C185
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf