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 035 01 19 000
Date submitted:	1/14/2019

Manufacturer:	Linet spol. s r.o.
Device Type:	Eleganza 2
Description:	hospital bed
Medical Device Identifier:	Model: 1GRA VZ/2016/587, VZ/2016/663, VZ/2017/121, VZ/2017/169, VZ/2017/271, VZ/2017/340, VZ/2017/399
Reason of Field Safety Corrective Action:	The material used during the time of production of KSA orders of new beds showed sufficient firmness of the side rail and minimal required firmness of the weld. Based on the reported cases in KSA we have revealed that the side rails and bed end may crack at critical spot of the weld during the standard use.
Remedy Action:	-No needed action to be taken by the user. The service partner of the manufacturer in KSA will contact all hospitals with above mentioned hospital bed model and will organize the preventive checks of the beds in the hospitals. -If your facility finds cracked siderail before the preventive action will be taken, please contact manufacturer or service organization. Priority will be assigned respectively.
Athorized Representative/Importer/Distributor:	Salehiya Trading Est.
Report Source:	NCMDR
Source Ref. Number:	0F60C30AED229
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Linet spol.pdf

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