Dive Brief:
- GE Healthcare has recalled older lines of incubators due to the risk of newborns falling because the door may not be closed properly. The Food and Drug Administration labeled the recall a Class I event, noting that it is a correction, not a product removal.
- GE Healthcare contacted customers in December after learning that the panel or porthole on its Care Plus and Lullaby incubators may not close properly. If the panel opens, the newborn inside the incubator could fall out.
- Users of the incubators have reported one serious injury related to the problem, according to the FDA’s notice. The recall affects more than 15,000 devices in the U.S.
Dive Insight:
Healthcare professionals use Care Plus and Lullaby incubators to provide heated and humidified air to newborns that are unable to regulate their own body temperature. As an enclosed bed environment, the incubators can provide the right conditions for newborns while also keeping them safely in one place.
Bedside panels or portholes enable healthcare professionals to access the babies. The problem, as GE Healthcare reported in its urgent field safety notice, is that the panels or portholes can look to be closed despite not being latched properly. If a canopy cover is used, it can hold a panel shut even if the latches are not locked correctly.
“If a bedside panel or porthole is not latched properly, the panel can detach and open, no longer protecting the patient from falling,” the FDA wrote. “The use of an affected incubator may lead to falls from the incubator due to improper door closure, and other injuries such as skin abrasions, bleeding, fractures and head trauma.”
GE Healthcare asked customers that want to continue using the devices to ensure the latches are secure each time they close the bedside panel. Healthcare professionals should manually check the latches on the porthole to ensure they are secure and pull the door to confirm it is latched properly.
In recent years, GE Healthcare has stopped supporting the Care Plus and Lullaby lines of incubators in some markets. The company now sells a line of Giraffe incubators, which are not affected by the recall.