GE Healthcare (NYSE:GE) has alerted health providers to inspect the bedside panels and latch areas of all Giraffe and Panda i-Res infant warmers, after 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 U.S. FDA. The FDA today said it had designated the recall as Class I, its most serious level.
The recall involves all Giraffe and Panda i-Res infant warmers made between 2007 and early this year — with a total 25,204 warmers affected in the U.S.
GE Healthcare officials said in a statement: “We take patient safety very seriously. Upon receiving reports of injury, we immediately began working with the hospitals to address the issue.”
The problem with the panels and latches appears to be related to human factors-related design.
The infant warmers have front or rear maneuvering handles, but healthcare workers sometimes were instead grabbing onto the panels to move the warmers, causing cracks or breaks in the latch areas, according to FDA.
If the latch on one of the panels of a warmer is cracked or broken, it could disengage and fall open when an infant comes in contact with it — which means an infant would not have any protection from rolling out of the warmer and falling.
GE Healthcare sent an Urgent Medical Device Correction notification letter to customers in March, followed by a press release and updated notification letter in June.
GE Healthcare asked health providers to inspect all warmers for cracked or broken panels or latches and to stop using them if there are any problems.
Health providers can continue to use the warmers if the panels and latches are operating properly, but they must add newly provided safety labels to the panel warning about the correct and incorrect ways to move the warmers. GE Healthcare also provided instructional posters for posting.
Said GE Healthcare: “To ensure units are safe to use, we are providing additional safety instructions to all hospitals with the warmers, and are replacing any damaged parts.”
This isn’t the first time that Giraffe and Panda warmers have been involved in a serious recall. For example, FDA in 2014 issued a Class I designation for a recall involving components that were installed backward during assembly.