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 086 05 14 000
Date submitted:	5/19/2014

Manufacturer:	Elekta Limited
Device Type:	MOSAIQ Couch Move Assistant (CMA)
Description:	Radiation Treatment Planning System Software
Medical Device Identifier:	versions 1.40 – 2.50
Reason of Field Safety Corrective Action:	When using CMA, if the user hovers the mouse pointer exactly above the Direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the Direction selection might change when the intention was only to move the mouse pointer to a different area of the screen.
Remedy Action:	The problem was introduced in MOSAIQ version 1.4 and is present in all released builds of versions 1.40 – 2.50 inclusive. The issue will affect users with Elekta linacs that have the Linac Remote Table License turned on. The problem will be resolved in a future MOSAIQ release and your site will be notified when the fix is available.
Athorized Representative/Importer/Distributor:	Analysis Device For Medical and Scientific Service ( ADMSS )
Report Source:	NCMDR
Source Ref. Number:	FC9E192E3D21E
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Elekta Limited.pdf

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