GE Infant Warmer Recalled Due to Oxygen Mixer Problems

A recall has been issued for resuscitation systems installed in infant warmers, due to a possible manufacturing error that may reverse the oxygen mixing concentrations, posing a risk of serious and potentially life-threatening injuries for infants receiving the treatment.

GE Healthcare notified consumers in October 2012 about potential problems’s with the company’s resuscitation systems with blenders, which are installed in GE Giraffe and Panda infant warmers. However, the FDA determined last week that the action constitutes a Class I medical device recall, suggesting that continued use of the resuscitation systems carries a reasonable probability of serious adverse health consequences or death.

The oxygen and air inlet fittings and labels located on the back panel of the device may have been reversed during assembly, which could cause the air and oxygen concentrations to potentially reverse. As a result, the setting of the blender knob may not inaccurately reflect the amount of oxygen produced.

The recall consists of field upgrade kits for GE Healthcare’s resuscitation systems with blender, installed in GE Giraffe and Panda infant warmers manufactured between April 2008 and September 2012.

GE Healthcare began notifying customers with affected units by sending an “Urgent Medical Device” letter in October, consisting of instructions and illustrations to allow hospital personnel to inspect and correct the device immediately and how to confirm their receipt of the letter.

Consumers with affected products should stop using the product immediately and contact GE Healthcare Customer Service at 1-800-345-2700 to schedule an inspection and mitigation.