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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 048 09 12 000
Date submitted: 9/9/2012
Manufacturer:Philips Healthcare
Device Type:computed tomography, Brilliance CT Big Bore
Description:computed tomography, X-ray
Medical Device Identifier:Software Versions 2.4.7 or 2.4.8
Reason of Field Safety Corrective Action: Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of "Ready for Scan" or scanning mode.
Remedy Action: The user is advised to close e-stop, turn the key switch and continue operating the system normally. Philips Healthcare will be installing a software update version 2.4.9 , A Philips Service Engineer will contact the customer for implementation of the software update on the affected system.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:EF7E762440247
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf