SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 110 06 16 000
Date submitted:	6/27/2016

Manufacturer:	Philips Healthcare
Device Type:	Philips DuraDiagnost X-ray system .
Description:	X-ray system
Medical Device Identifier:	All DuraDiagnost X-ray systems
Reason of Field Safety Corrective Action:	Audible Exposure Termination Beep May Not be Audible
Remedy Action:	Philips will supply the FCO71200155 as field action to address above issues free of charge. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented.
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	ACDADE311F2B4
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Healthcare 2.pdf

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