GE Healthcare is recalling more than 25,000 infant warmers after two infants fell and fractured their skulls. The Food and Drug Administration (FDA) has classified the move as a class 1 recall, the most serious type, according to the warning.
The Panda i-Res Infant Warmers and Giraffe Infant Warmers typically are used in hospital labor and delivery areas and neonatal intensive care units, respectively, for infants unable to maintain their own body temperature. However, bedside panels and latch areas can crack or break when the warmers are moved via the bedside panels, and infants can fall from the warmer, according to the warning. GE has received 338 complaints, including two skull fractures.
Model numbers involved in the recall begin with 2063568-001-, 2063570-001-, M1112198- and M1118179-.Customers should inspect the warmers for cracks or damage and stop using if either is present. GE will replace damaged parts.
If the warmer is not damaged, customers should use GE-provided safety labels and posters with instructions about the correct ways to move the unit using the front and rear handles and check for damage.
Customers with questions can contact the company at 800-437-1171 and can report adverse events to the FDA's MedWatch Adverse Event Reporting Program at https://www.fda.gov/node/360543.
