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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 157 05 17 000
Date submitted: 5/31/2017
Manufacturer:Philips Healthcare
Device Type:The DuraDiagnost systems
Description:Radiographic Systems, Digital
Medical Device Identifier:DuraDiagnost R1.0 (Product Number 712210)
DuraDiagnost R2.0 (Product Number 712211)
DuraDiagnost R3.0 (Product Number 712211)
Reason of Field Safety Corrective Action:As a result of a report from the field, Philips discovered that some welding joints on the vertical carriage brackets of the tube stand may crack.
Remedy Action:Philips will inspect the welding joints of tube stand vertical carriage brackets and install the safety hooks structure through FCO71200173 free of charge, which will prevent tube arm assembly from falling down even if all the bracket welding joints were cracked.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:306F1235FC1E2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf