Following more than 300 complaints involving problems with infant warmers used in hospitals, including at least two babies who fell and suffered a skull fracture, GE Healthcare has recalled all Giraffe and Panda i-Res infant warmers, due to a risk that the bedside panels and locking mechanisms may crack or break.
The infant warmer recall was announced by the U.S. Food and Drug Administration (FDA) on July 12, following reports that suggest the bedside panels and latches are prone to break, posing a serious and potentially life-threatening risk for babies.
The infant radiant warmers are primarily used in the hospital Labor and Delivery areas and in Neonatal Intensive Care Units. They provide infrared heat in a controlled manner to infants who are unable to maintain their body temperature.
The warmers are equipped with glass side wall panels, which are designed to prevent the infant from falling out of the warmer. According to the recall, these glass panels, and their locking mechanisms, may be prone to crack, which would allow the safety panels to fall open and no longer protect the infant from falling off of the warmer.
To date, the FDA is aware of at least 338 complaints related to the bedside panels and latches breaking. Two of these incidents involved newborns who fell from the GE warmers and suffered skull fractures.
The recall includes all lots of Giraffe Infant Warmers and Panda i-Res Infant Warmers that were manufactured by GE Healthcare of Chicago, Illinois from October 1, 2017 through February 28, 2019, where they were distribute throughout the U.S. to healthcare facilities. The warmers are marked with a model number ranging from 2063568-001-XXXXXX, 2063570-001-XXXXXX, M1112198-XXXXXX and M1118179-XXXXXX.
GE Healthcare issued an Urgent Medical Device Correction notice earlier this year on March 15, 2019. The notice included additional safety labels and advised customers to routinely inspect the bedside panels and latches for damage, and to stop using the warmers if any damage is noticed. However, following additional incident reports, the manufacturer determined a safety recall was required.
The FDA has categorized this recall as a Class I recall, indicating the recall involves a dangerous or defective product that has a high probability of causing serious adverse health consequences, including death to the user.
Customers are being asked to follow the instructions detailed in the Urgent Medical Device Correction notice and to contact GE Healthcare customer service at 1-800-437-1171 for additional questions or concerns regarding the recall.