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 072 06 17 000
Date submitted:	6/22/2017

Manufacturer:	EOS Imaging
Device Type:	ROTH MOBELI grab handles used with EOS System
Description:	Radiographic Systems, Digital
Medical Device Identifier:	• MOBELI Stabi Vario grab handle (ROTH catalogue number 14002 96 S - EOS imaging catalogue number 9000111773) • MOBELI Dual grip grab handle (ROTH catalogue number 14002 25 S – EOS imaging catalogue number 9000111774)
Reason of Field Safety Corrective Action:	EOS imaging is initiating this Medical Device Removal of the ROTH MOBELI grab handles used with EOS System. To date, EOS imaging has received one complaint relating to the detachment of a grab handle located outside the gantry of the EOS System and leading to the patient fall. The ROTH MOBELI grab handles shall never be used outside the EOS gantry to help the patient for standing up.
Remedy Action:	Please immediately discontinue use of all the ROTH MOBELI grab handles with EOS System and remove all the affected units from your inventory (whether in Radiology, Central Supply, Shipping & Receiving and any other relevant location). Segregate the units in a secure place, pending return to EOS imaging.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCMDR
Source Ref. Number:	11A562E506203
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	EOS imaging.pdf

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