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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 066 04 15 000
Date submitted: 4/14/2015
Manufacturer:GE Healthcare
Device Type:D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
Description:Water trap, condensate
Medical Device Identifier:Model :D-Fend p/n 876446-HEL Lot : J9964985, J10201698, J10258248, J10284871, J10284872, J10344108

Model : D-Fend+ p/n 881319-HEL Lot : J9906966, J9965152, J10258251, J10300071
Reason of Field Safety Corrective Action:Potential loss of gas monitoring due to occlusion of D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
Remedy Action:GE Healthcare will replace all affected products at no cost to you.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:765E08A5CC24D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf