GE Healthcare Inc. is recalling a total of 22,961 infant care incubators and warmers in the U.S. due to defects that could cause the child to fall.
The Marlborough, Mass.-based privately held biotechnology company is recalling all units of its Giraffe Incubators and Giraffe OmniBeds, as well as its Giraffe Incubator Carestations and Giraffe OmniBed Carestations, manufactured between April 2008 and September 2019.
The U.S. Food and Drug Administration identified it as a Class I recall, the most serious type of recall.
Incubators are small beds enclosed in a clear, hard plastic that is temperature-controlled for infants who are unable to maintain their body temperature, while warmers are small beds with heaters used for the same reason. Healthcare providers can give care to infants through holes, or portholes, on the side of the incubators.
The company initiated a recall of the devices on Oct. 11 because the bedside panels can be upright and look closed but not be securely latched. The portholes can also look closed when not securely latched.
If a canopy cover is used, it can hold the bedside panel or porthole door closed without being securely latched. If an infant comes in contact with a bedside panel or porthole that is unlatched, the panel or porthole can disengage and fall open, no longer protecting the infant from falling.
GE Healthcare has received six reports of infant falls, resulting in skull fractures, hematoma and edema, however, no infant deaths were reported.