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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 097 08 18 000
Date submitted:	8/29/2018

Manufacturer:	Leica Microsystems Inc.
Device Type:	Leica M525 F20
Description:	Microscopes, Light, Operating
Medical Device Identifier:	All Leica M525 F20 Microscope Systems
Reason of Field Safety Corrective Action:	Leica Microsystems received five customer complaints stating that users inadvertently tipped over their Leica M525 F20 Microscope System. In four cases it was confirmed, that the issue occurred when users handled the microscope while the swing arm was in fully extended position (see Figure 3 in the attached FSN). In all cases the Leica M525 F20 did not cause or contribute to serious injury. The five complaints occurred in five different countries over a timeframe between the years 2010 and 2017. The Leica M525 F20 was introduced in the year 2009 with more than 1000 instruments distributed globally up to date.
Remedy Action:	Check the information in the attached FSN.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System
Report Source:	NCMDR
Source Ref. Number:	0BE42F93131C4
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Leica.pdf

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