Certain Giraffe Incubators and OmniBed systems may contain a defect that reverts their oxygen and temperature settings back to default when they are shut off or in case of power failure. GE Healthcare warns.
Certain Giraffe systems manufactured between Aug. 1, 2012, and Dec. 20, 2013, may not "remember" their previous settings when turned off and then on or in case of power failure, reverting to default oxygen or temperature settings that may not be appropriate for the patient.
"An inaccurate setting for temperature or oxygen regulation may predispose patients to high or low temperature or high or low environmental oxygen delivery, depending on the default parameters," according to a GE press release. "These conditions would be evident through typical patient monitoring in use by clinicians."
GE issued a field correction in January and began notifying customers with instructions on how to mitigate the issue. The company also dispatched field service engineers to inspect the systems and upgrade any affected devices.
No patients have been injured in associated with the defect, GE said.
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