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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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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
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