On December 17, the FDA announced a Class 1 recall for nearly 23,000 GE Giraffe Incubators, Giraffe OmniBeds, and Carestations made between April 2008 and September 2019.
Incubators are small beds enclosed in clear, hard plastic that are temperature-controlled. Infant warmers are small beds with heaters over the bed to warm infants. Both are used in hospital settings.
The problem is that the bedside panels and porthole doors can look closed when they are not actually securely latched. If an infant touches a panel or porthole that is unlatched, it can open and the infant can fall.
GE Healthcare has received 6 reports of infants falling out and suffering injuries like skull fractures, hematoma or edema (swelling).
In July 2019, GE Healthcare issued another Class I recall for all Giraffe and Panda i-Res infant warmers, after 338 complaints of bedside panels opening. Two infants fell from the beds and suffered skull fractures, but no deaths were reported, according to the FDA.
According to the most recent recall, GE Healthcare says hospitals can continue to use their infant warming beds and incubators, so long as users pull on the bedside panel or porthole doors to check for a secure latch.