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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 082 04 12 000
Date submitted: 4/21/2012
Manufacturer:Draeger Medical Systems Inc
Device Type:Gas supply System, G40600
Description:Gas supply System
Medical Device Identifier:RE 1200 Basic and OM set KV with the serial numbers: ASCM-0511, ASCM-0512, ASCM-0507 installed between January, 2012 and March, 2012
Reason of Field Safety Corrective Action:Regarding the pre-installation of a gas control unit, Draeger noticed. They were not in the regulator function as the cartridge G40600 reduced in all cases with the required torque. When the cartridge is not used as specified, it may in extreme cases, cause the switch to the other supply side of your gas supply system is not functioning properly.
Remedy Action:Cartridge subsequently should be calibrated tightened with the required torque so that malfunctioning can no longer occur as described here in above.
Athorized Representative/Importer/Distributor:Draeger Arabia Co. Ltd., Riyadh, (01) 4623000
Report Source:NCMDR
Source Ref. Number:20369B56AF1F6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments