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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 053 05 11 000
Date submitted: 5/16/2011
Manufacturer:Draeger Medical Systems Inc
Device Type:Gas Management Systems
Description:Gas Management Systems
Medical Device Identifier:MX48730\MX48570
Reason of Field Safety Corrective Action:f gas cylinders are not filled up evenly, the cylinder bank gauge will not show the actual gas level of the cylinder bank but only the pressure of the cylinder with the highest pressure value.
Remedy Action:Following the amendment to the EN 737-3 standard, since 1998 all cylinder connections of the manifold tube must be fitted with a non-return valve. These non-return valves cause only the pressure of the fullest cylinder to be indicated at any given time.
Athorized Representative/Importer/Distributor:Draeger Arabia Co. Ltd., Riyadh, (01) 4623000
Report Source:NCMDR
Source Ref. Number:83400815A0180
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:No Attachments