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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 12 17 000
Date submitted: 12/14/2017
Manufacturer:GE Healthcare
Device Type:CARESCAPE R860 ventilator
Description:Ventilators
Medical Device Identifier:CARESCAPE R860 ventilators with software version 10SP05
GTIN # 00840682102346
Reason of Field Safety Corrective Action:There is a potential for the display processor to experience an unexpected failure. If this failure occurs, the device screen will temporarily go blank and will then display an Error Code “EC01 XX”. The blank display results in loss of monitored data being displayed to the user. There have been no injuries reported as a result of this issue.
Remedy Action:GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:18EB828AEB2FA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf