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 098 01 16 000
Date submitted:	1/28/2016

Manufacturer:	Leica Microsystems Inc.
Device Type:	Leica M525 OH4 and Leica M720 OH5
Description:	Surgical microscope systems
Medical Device Identifier:	Leica OH4/ OH5 Surgical Microscope Stands with 400W illumination manufactured from 1st October 2012 until 1st September 2014 Multiple serial numbers affected
Reason of Field Safety Corrective Action:	An electronic component in one of the two illumination units can potentially overheat, resulting in minimal smoke and odor emanating from the ventilation openings of the illumination units.
Remedy Action:	A Leica Microsystems representative will be contacting your facility to arrange the no-cost replacement of the power supply output cables with improved cables including a filter coil in both 400W illumination units of your instrument as soon as possible.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System
Report Source:	NCMDR
Source Ref. Number:	34786AAF50215
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Leica Microsystems.pdf

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