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GE Healthcare recalls Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-r
Recalled May 14, 2014 · FDA recall Z-1547-2014 · GE Healthcare
Hazard
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. · FDA Class II
Units
50 units
Sold at
Worldwide Distribution.
Description
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Product
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →