GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall
MedSun: Newsletter #84, May 2013

FDA MedWatch Safety Alert

The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new information in its place (over-write) when the device turns “on” or recovers from a power failure. When this occurs, the heater or oxygen delivery option will turn “off” and the new set point will be “0”. In addition, alarms may not appropriately alert users that heater or oxygen delivery options are “off” or that the set points are less than intended.

Additional Information:

FDA MedWatch Safety Alert. GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall. April 24, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349283.htm


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