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 001 12 17 000
Date submitted:	12/4/2017

Manufacturer:	Elekta Inc
Device Type:	IVIEWGT SYSTEM
Description:	Accelerator system, linear
Medical Device Identifier:	iViewGT SYSTEM
Reason of Field Safety Corrective Action:	Potential for the iViewGT and XVI detector arms to extend due to gravity.
Remedy Action:	Corrective Action #1: Release of Important Field Safety Notice Elekta, will send Important Field Safety Notice 200-01-103-082 to all affected customers from 06¬DEC-17. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. Corrective Action #2: Microswitch Setup Test Kit A tool kit which will enable service engineers to test the setup of the microswitch, and correct if necessary, will be produced and released.
Athorized Representative/Importer/Distributor:	Medical Regulations Gate
Report Source:	NCMDR
Source Ref. Number:	EE8064D1162B9
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Elekta Ltd.pdf

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