X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 123 09 18 000
Date submitted: 9/27/2018
Manufacturer:GE Healthcare
Device Type:Giraffe OmniBed
Description:Incubator
Medical Device Identifier:Giraffe OmniBeds shipped from 2000 to 2011 with Serial Numbers starting from HDGD00001 to HDGQ50183.
Reason of Field Safety Corrective Action:Canopy seals not cleaned properly on systems with original seal design, potential contamination.
Remedy Action:GE Healthcare will provide a Giraffe OmniBed Cleaning & Care Guidelines poster for display by your system. No other correction is required.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:1B2945551DFB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare 2.pdf