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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 101 06 15 000
Date submitted: 6/18/2015
Manufacturer:GE Healthcare
Device Type:single and dual LCD monitor suspensions used on Precision 500D classical radiographic and fluoroscopic (R&F) systems, Precision RXi 23A/32A analog systems, Precision RXi digital systems and Precision MPi fluoroscopic imaging systems.
Description:Imaging Device
Medical Device Identifier:Single LCD Monitor Suspension: 2385123-2 and Dual LCD Monitor Suspension: 2385125-2 as used on the following systems: - Precision 500D classical R&F systems, - Precision RXi 23A/32A analog systems, - Precision RXi digital systems and Precision MPi fluoroscopic imaging systems. See attached appendix for the list of affected systems ID’s.
Reason of Field Safety Corrective Action:Potential fall of single/dual LCD monitor by detaching from suspension.
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:817E66A51521F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare-2.pdf