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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 107 06 14 000
Date submitted: 6/26/2014
Manufacturer:Philips Medical Systems Nederland B.V.
Device Type:DuraDiagnost X-ray System
Description:Imaging, X-ray System
Medical Device Identifier: The following DuraDiagnost serial numbers (SN) are affected, you can find your serial number on the product label: SN130001 / SN130002 / SN130003 / SN130004 / SN130005 / SN130006 / SN130007 / SN130009 / SN130010 / SN130011 / SN130012 / SN130013 / SN130014 / SN130015 / SN130016 / SN130017 / SN130018 / SN130019 / SN130020 / SN130021 / SN130022 / SN130023 / SN120001 / SN120002 / SN120003
Reason of Field Safety Corrective Action:If the screw threads for the mounting of the x-ray tube were not properly aligned during installation or service, the tube could be unstable.
Remedy Action:Philips Healthcare will provide a new X-Ray tube arm structure to support the X-Ray tube assembly, which is less susceptible to screw thread damage during servicing or replacement. A Philips Healthcare Service Engineer will contact you to install the solution.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd., (011) 4628060
Report Source:NCMDR
Source Ref. Number:1295FB284D217
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips.pdf