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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 05 17 000
Date submitted: 5/4/2017
Manufacturer:Philips Healthcare
Device Type:DigitalDiagnost 3.1.x
Description:Radiographic Systems, Digital
Medical Device Identifier:DigitalDiagnost Release 3.1.x
Reason of Field Safety Corrective Action:A firmware anomaly inside the detector (4343RC) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not, resulting in not correctly acquiring the X-ray image.
Remedy Action:Philips plans to install a software upgrade in affected systems, which will eliminate this issue.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:0FB7DF5BA12A1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare (DigitalDiagnost ).pdf