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Class I Recall Issued for GE Healthcare Incubators

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GE Healthcare designed two products – the Giraffe OmniBed and the Giraffe Incubator – to provide thermal and developmental care to newborn babies.  These products are used to maintain the body temperature and, in some models, the oxygen level of newborn babies.

The Giraffe OmniBed can function in either the closed mode as an incubator or in the open mode as a warmer, and can transition from one mode to another depending upon the user’s demand.  The Giraffe Incubator provides heat through a closed, temperature-controlled environment that maintains the body temperature of a newborn infant, with some models containing a  controlled oxygen delivery system that can be used to provide oxygen to newborn babies, as well.

The Food and Drug Administration (FDA) issued a Class I Recall in April for certain models of GE’s Giraffe OmniBed and Giraffe Incubators manufactured and distributed between August 2012 to December 2012.  Those models being recalled may, when recovering from a power failure, delete stored information and then enter new erroneous information in its place.  Should this occur, the heater or oxygen delivery option is turned off, the new set point will be “0”, and alarms may fail to alert healthcare personnel that either the heater or oxygen delivery options are “off” or that  set points are lower than intended.

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Any newborn baby using these devices during a power outage may suffer serious adverse health consequences, including death, due to this malfunction.  Adverse health consequences include inaccurate body temperature, which can result in either hypothermia (dangerously low body temperature) or hyperthermia (dangerously high body temperature), and inaccurate oxygen regulation, which can result in hypoxia (low blood oxygen) or hyperoxia (high blood oxygen).

GE Healthcare will correct all affected devices at no cost to customers and urges all healthcare professionals to report any adverse reactions related to use of the Giraffe OmniBed and/or Giraffe Incubator to the FDA’s MedWatch Safety Information and Adverse Reporting Program online or by calling their toll free number: 1-800-332-1088.

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