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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NCAR Recall

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Reference Number:	mdprc 110 04 12 000
Date submitted:	4/24/2012

Manufacturer:	V.Guldmann A/S
Device Type:	Ceiling hoist, Trolley sets, GH3/GH1 Trolley
Description:	Ceiling hoist, Trolley sets
Medical Device Identifier:	Model number: 550097; Serial no.: All Lot/batch no.: All
Reason of Field Safety Corrective Action:	The GH3 Trolley can fall down, in case of the hoist is placed straight underneath the safety lock (the safety device of the combi lock) and then the staff activate the combi lock the safety lock is closing the rail, preventing the hoist moving out of the rail, when the traverse rail moves away from the fixed rail. Under this special circumstance and the hoist is moved extremely sideways to get the traverse rail free of the combi lock the safety lock can be bypassed, and the hoist can move out of the rail.
Remedy Action:	To prevent the GH3 Trolley from falling down, V. Guldmann A/S will remove the inner guide bush on all GH3 and GH1 trolley sets according to the attached.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	DK-2012-04-20-007
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	V.Guldmann.pdf

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