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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 212 08 15 000
Date submitted:	8/30/2015

Manufacturer:	Handicare AB
Device Type:	Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37
Description:	Stationary patient lifting system, line-powered
Medical Device Identifier:	Model: 50400226, 50400237, 50400238 See attached FSN
Reason of Field Safety Corrective Action:	Transition gate manual is used to connect two rails in a ceiling lift system. Typically it connects a single rail to a traverse system. The design of Transition gate manual forces the safety pins in the gate to their upper, open, position when the rails are aligned and ensures that the safety pins are pushed back to their lower, closed, positions when the rails are pulled apart. If the safety pin is pushed repeatedly by one of the trolley types mentioned above, the wiggling of the trolley will cause a movement of the safety pin upwards . This can only occur if Transition gate manual is used in combination with the types of trolleys specified above, and with a low load or non-load onto the lift. The friction between the bushing and the safety pin can hinder the pin from falling down by itself, leaving the rail open and allowing the trolley to pass and fall to the floor.
Remedy Action:	Advice on actions to be taken by the distributor and the user Identify all installations with the affected combination of articles and take them out of service. Report back to Handicare AB and order stop plate kits. Retrofit the stop plates before taking the device into service again. Installations with the combination of Transition gate manual and trolleys listed above must be upgraded with stop plates to the trolley. Stickers showing stop zones 30 cm from the gate must also be attached to installed rails. In future deliveries, all models of Transition gate manual will include stickers to mark the stop zones on the rail, and information about fitting the trolley types listed above with stop plates before use in combination with Transition gate manual. The design of the trolleys will be updated to include stop plates.
Athorized Representative/Importer/Distributor:	Al Safwa Dimensions
Report Source:	NCAR
Source Ref. Number:	SE-2015-08-14-019
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Handicare AB.pdf

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