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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 062 07 15 000
Date submitted: 7/30/2015
Manufacturer:GE Healthcare
Device Type:imtmedical AG, EVair Compressor (an optional accessory to GE Healthcare Engstrom Carestation, Engstrom Pro, and CARESCAPE R860 ventilators)
Medical Device Identifier:EVair compressors (M1230847, M1230849) that were provided to GE Healthcare by imtmedical prior to May 30, 2015 may be affected by this issue. See the serial number list provided in the appendix for a full list of affected devices.
Reason of Field Safety Corrective Action:Imtmedical has identified that potential friction of cables and tubing internal to the EVair compressor may result in an inability for the compressor to output compressed air.
Remedy Action:Imtmedical will provide GE Healthcare with field correction kits (REF 302.810.000) to GE Healthcare. GE Healthcare will contact all affected customers, and correct all affected systems.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:C3EF016570288
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf