Published by What’s the problem?
The recall affects all GE Giraffe and Panda i-Res infant warmers manufactured between 2007 and early 2019, according to an FDA Recall Notice. The agency designated this action as a Class I Recall, which is reserved for “products or devices which may cause serious injuries or death.”
The problem with the panels and latches on GE infant warmers appears to be a “human factors-related design” issue, FDA said.
The infant warmers have front and rear maneuvering handles, but in many cases, healthcare workers were grabbing onto the panels to move the devices, causing cracks or breaks in the latch areas, the agency found.
If the latch on one of the panels of an infant warmer is cracked or broken, it could disengage and fall open when a baby comes into contact with it, leading to disastrous consequences.
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Urgent Medical Device Correction Notification
In March, GE Healthcare sent out an Urgent Medical Device Correction notification urging customers to inspect all infant warmers for cracked and/or broken panels or latches, and to stop using them immediately if there are any problems.
The company said healthcare 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.
In 2014, FDA issued a Class I recall for GE Giraffe and Panda i-Res infant warmer components that were installed backward during assembly.
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