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FDA issues class I recall for GE Healthcare’s resuscitation systems

GE Healthcare has recalled its Giraffe and Panda Warmer Infant Resuscitation systems as the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

These devices are used to resuscitate infants and newborns and regulate body temperature.

The US Food and Drug Administration (FDA) announced the recall, explaining that these recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in newborns (neonates), and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia).

This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality.

The affected products were manufactured from April 1, 2007 through October 31, 2013 and distributed from October 1, 2007 through October 31, 2013.

Earlier on November 18, 2013 GE Healthcare sent an Urgent Medical Device Correction letter, with a return receipt, to all affected customers.