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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 143 07 16 000
Date submitted:	7/26/2016

Manufacturer:	Philips Healthcare
Device Type:	Philips IntelliVue Patient Monitors.
Description:	Patient Monitors
Medical Device Identifier:	Model: MX400 Product: 866060 Model: MX430 Product: 866061 Model: MX450 Product: 866062 Model: MX500 Product: 866064 Model: MX550 Product: 866066
Reason of Field Safety Corrective Action:	If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patient’s current condition.
Remedy Action:	Philips is voluntarily initiating a correction consisting of: • Distribution of this Field Safety Notice (FSN). • A Software upgrade for affected Philips IntelliVue Patient Monitors.
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	DF1242A70E1E8
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Healthcare.pdf

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