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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 144 04 14 000
Date submitted: 4/28/2014
Manufacturer:GE Healthcare
Device Type:Giraffe and Panda Warmers with Nellcor SpO2 Sensors
Description:Warming Units, Patient, Radiant, Infant
Medical Device Identifier:Warmers integrated with Nellcor SpO2 Sensors: (1) Giraffe, (2) Panda Freestanding, (3) Panda iRes, (4) Panda Wall-Mount; (5) Nellcor SpO2 Upgrade Kits
Reason of Field Safety Corrective Action:Alarms May Not Activate as Expected, Potentially Resulting in False-Positive/-Negative Saturation and Pulse Rate Alarm Notifications
Remedy Action:Healthcare facilities may continue to use the above warmers with the following instructions:

(1) When using an affected warmer with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternative form of SpO2 measurement.

(2) Before using an affected warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital biomedical or other qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix (See attached).

(3) If the test activates a "Low Pulse Rate" alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. Alarm functionality must be rechecked after every service event requiring access to the internal electronics and during annual preventive maintenance, until revised software is installed.

(4) If the test does NOT activate a "Low Pulse Rate" alarm, remove the warmer from clinical service and contact your GE Healthcare local service representative.

GE Healthcare will correct all affected systems with a software revision at no cost to you.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:84A79A345A253
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE.pdf