GE Healthcare has initiated a recall of its older incubator models, Care Plus and Lullaby, due to a risk that newborns could fall out because of improperly closed doors. The Food and Drug Administration (FDA) has classified this recall as a Class I event, indicating it’s a serious correction rather than a removal of the products from the market. This decision was made following a report of a severe injury associated with the use of these incubators.
The issue stems from the incubators’ panels or portholes not closing securely, which may appear to be shut without being properly latched. This problem was identified in December when GE Healthcare notified its customers of the potential risk. Over 15,000 devices in the U.S. are affected by this recall.
The Care Plus and Lullaby incubators are designed to provide a controlled environment for newborns who cannot regulate their body temperature by offering heated and humidified air within an enclosed space. They feature bedside panels or portholes for healthcare professionals to access the infants. However, if these access points are not latched correctly, they could detach and open, posing a risk of falls and related injuries such as skin abrasions, bleeding, fractures, and head trauma.
GE Healthcare has advised customers who wish to continue using these devices to ensure the latches are securely fastened each time the panel is closed. This involves manually checking and pulling on the doors to confirm they are properly latched. It’s important to note that GE Healthcare has phased out the Care Plus and Lullaby incubator lines in some markets and currently promotes its Giraffe line of incubators, which are not subject to this recall.