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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 015 10 12 000
Date submitted: 10/8/2012
Manufacturer:Philips Healthcare
Device Type:Computed tomography system, Extended Brilliance Workstation (EBW)
Description:Computed tomography system
Medical Device Identifier:Extended Brilliance Workstation with running software version(s) 4.0.2, V4.5.2 or V4.5.3
Reason of Field Safety Corrective Action:1. When translating the Calcium Scoring (CS) results into Chinese, the percentile is not reported accurately. 2. In the Calcium Scoring (CS) protocol, the protocol is switched to Mass Score but the protocol name remains Agatston. 3. Spline measurement values do not update when adding control point (CP) and when changing the length of the line. 4. In the CT Viewer (CTV) PET studies being loaded from remote with Slope different than 1, appear incorrectly in 2D scene and are not displayed with the correct SUV values. 5. Loading PET images in the CT Viewer (CTV) \ Quick Review from remote with Slope different than 1, the images with the different Slope appear incorrectly with wrong SUV values in Perception and in QR.
Remedy Action:Action to be taken by customer: • Problem Description Number 1: Use a different report language other than Chinese in Calcium Scoring. • Problem Description Number 2: Do not switch to Agatston protocol before clicking "ok" in the "Lateral Thickness dialog box" in Calcium Scoring. • Problem Description Number 3: Do not add control point to a spline line. Edit the existing lines, or use a different sort of line in the Common Tools – Spline Measurement. • Problem Description Number 4: In the CT Viewer (CTV), first copy the data to Local and then load to CT Viewer/Quick Review and measure SUV values. Or, load the data to CT Viewer and measure SUV values in Slab stage • Problem Description Number 5: In the CT Viewer (CTV) \ Quick Review, copy the data to Local and then load to CT Viewer/Quick Review and measure SUV values. Or, load the data to CT Viewer and measure SUV values in Slab stage. The Philips service department will contact all of the sites to arrange a time to conduct the appropriate field correction and implement the software update.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:C48E320B3D1CC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: philips.pdf