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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 122 01 15 000
Date submitted: 1/28/2015
Manufacturer:GE Healthcare
Device Type:Engstrom Carestation and Engstrom Pro ventilators
Description:ventilator
Medical Device Identifier:Engstrom Carestation and Engstrom Pro ventilators that were provided with an accessory cart as part of the original order, with Engstrom serial numbers CBCN01062 through CBCQ01396. Also affected are accessory carts shipped independently of an Engstrom ventilator from October 2009 through September 2011.
Reason of Field Safety Corrective Action:Specific combinations of Engstrom ventilator casters and bases have been identified to pose an increased likelihood of failures of the caster mounting hardware.
Remedy Action:GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare Service Representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:6A4C202A2D12D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE healthCare.pdf