The FDA labeled it a Class I recall, and it’s not the first for GE Healthcare’s Giraffe products. Giraffe Incubators were recalled in October 2013 due to components that were installed backward during assembly, potentially resulting in devices delivering inaccurate levels of oxygen that may lead to over- or under-oxygenation that could cause infants injury or even death.
In July of this year, another Class I recall was issued after GE Healthcare alerted health providers to inspect the bedside panels and latch areas of all Giraffe and Panda i-Res infant warmers, following 338 complaints of panels malfunctioning. In two cases, infants fell from warmers and cracked their skulls, but there have been no reports of deaths, according to the FDA.
The latest recall also involves the bedside panels, as the Giraffe products’ panels can be upright and look closed but not be securely latched, as can portholes. If an infant contacts either the panel or porthole when unlatched, it may fall open and fail to protect the infant from falling.
There have been six reports of infant falls that include injuries such as skull fractures, hematoma and edema. However, no deaths were reported.
Affected products were manufactured between April 2008 and September 2019, while GE Healthcare listed the distribution dates between April 2000 and September 2019. The company has recalled 22,961 devices in the U.S. since initiating the recall on Oct. 11.
GE Healthcare told users that they can continue using the Giraffe Incubator, OmniBed, Incubator Carestation and OmniBed Carestation systems by following a set of instructions. The instructions include ensuring the bedside panel is latched and pulling the porthole doors to make sure they are latched as well, along with ensuring that healthcare professionals are aware of the instructions for latching the panels and doors.