GE Healthcare has recalled two of its infant warmers—bedlike hospital devices designed to radiate heat and track the health of newborns—due to side panels and latches that may crack, break or open, allowing infants to fall.
The products include all models of both the Panda iRes, typically used in labor and delivery settings, and the Giraffe warmer, used in neonatal intensive care units. According to the FDA, the recall affects 25,204 devices manufactured and sold in the U.S. since 2007.
The agency designated the move as a Class I recall, its most serious, with the potential for severe injuries or death. No fatalities have been reported among a total of 338 device complaints, though two infants fell from warmers and fractured their skulls, the FDA said.
According to the recall notice, the devices’ latches can break under stress if the warmers—which each weigh about 100 kg or 220 lbs—are moved using their bedside panels instead of the maneuvering handles.
GE Healthcare notified customers of the issue in March and posted an update about its recall efforts in June. The company instructed providers to stop using any warmer with damaged panels or latches and furnished new caution labels and posters that demonstrate how to properly move the device.
“We take patient safety very seriously. Upon receiving reports of injury, we immediately began working with the hospitals to address the issue," a GE Healthcare representative said in a statement. "To ensure units are safe to use, we are providing additional safety instructions to all hospitals with the warmers, and are replacing any damaged parts.”
The agency previously issued a Class I recall for the resuscitation systems of GE Healthcare’s Giraffe and Panda warmers in 2014, after it was found that certain oxygen and inlet fittings had been installed backward during the devices’ assembly and could restrict air flow.
Editor's note: This story was updated with a statement from GE Healthcare.