X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 120 02 12 000
Date submitted: 2/19/2012
Manufacturer:Philips Healthcare
Device Type:Computed Tomography, Brilliance Workspace Portal
Description:Computed Tomography
Medical Device Identifier:Brilliance Workspace Portal running software version 2.5.2 or 2.6.0.
Reason of Field Safety Corrective Action:Incorrect display of Standardized Uptake Value (SUV) values in the Quick Review and CT Viewer application when loading from a remote device.
Remedy Action:Philips will install software update version 2.6.1 on all affected Workspace Portals to address this problem. Philips also issued instructions for users (Attached).
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:5AC5ACA58B2FB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf