Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 117 06 18 000
CARESCAPE R860, ENGSTROM CARESTATION and ENGSTROM PRO
Medical Device Identifier:
Neonatal Flow Sensor Cable (1505-5604-000 Lot # 1804) used on CARESCAPE R860 1506-8600-000, ENGSTROM Carestation 1505-9000-000, Engstrom Pro 1505-9003-000. Contained in Neonatal Software Upgrade Kit 2080496-010.
Reason of Field Safety Corrective Action:
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. If the exposed wires break, primary ventilation parameters could be lost (Flow and Tidal Volume). This issue may cause indirect but reversible changes in the patient’s condition as these parameters, among other information, are used in choosing appropriate ventilator settings for the patient
GE Healthcare will replace all affected products at no cost to you. Complete and return the attached “Customer Response” form via e-mail to Recall34092.NFSCable@ge.com and GE Healthcare will provide replacement cables at no cost to you.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.