GE Healthcare has recalled the Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestations. The U.S. Food and Drug Administration (FDA) identifies these as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.
Incubators and warmers are used for infant care in a hospital setting. They are small beds enclosed in clear, hard plastic that is temperature-controlled for infants who are unable to maintain their body temperature on their own. Infant warmers are small beds with heaters over them to warm infants who are unable to maintain their body temperature on their own. Healthcare providers can give care to babies through holes in the sides of the incubator, also called portholes.
The products were recalled 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.
The firm has received six reports of infant falls with injuries such as skull fractures, hematoma and edema. No deaths were reported.