Recalls

GE Healthcare recalls Infant Warming Systems due to potential safety hazard

preemie baby 435x293 GE Healthcare recalls Infant Warming Systems due to potential safety hazardScrews from the heater head of some GE Healthcare Infant Warming Systems used to provide warmth to newborns at medical facilities have come loose and fallen onto the bed of the product, causing injuries in at least two babies. As a result, GE Healthcare is recalling certain models and making health care professionals who work in labor and delivery departments and neonatal intensive care units aware of this potential safety hazard and the risk of thermal injuries to patients.

GE Healthcare’s Infant Warmer Systems provide varying thermoregulation for infants. They provide radiant heat over bassinets in nurseries, complete thermoregulation in the neonatal intensive care unit care stations, or wall-mounted warming units in the delivery room. The recall affects several models and involves 32,073 units distributed in the U.S. and another 7,712 distributed outside the U.S.

The issue arises only when the “Heater Head” of the device has been improperly assembled. Staff at medical facilities where the infant warming systems are used have been advised to check to ensure that the screws are tightened through an Urgent Field Safety Notice issued by GE Healthcare.

Any injuries or issues associated with these Infant Warming Systems should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA Enforcement Report
GE Healthcare Urgent Field Safety Notice