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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 061 09 17 001
Date submitted: 9/26/2017
Manufacturer:Philips Healthcare
Device Type:Brilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128
Description:Computed Tomography
Medical Device Identifier:Running software versions: 4.1.6

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NCMDR update codes:

Brillianc iCT, Brilliance iCT SP
Reason of Field Safety Corrective Action:Upon completion of scan procedure during Bolus tracking on a Brilliance iCT with software version 4.1.6, no images were generated. This leads to unavailability of raw data for offline reconstruction.
Remedy Action:A Philips Field Service Engineer will contact you to schedule the updates to your system.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:BC3744C3D62D0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Brilliance.pdf