Class I Recall for GE Neonatal Systems

The U.S. Food and Drug Administration (FDA) has designated GE’s recall for Giraffe and Panda neonatal infant warmers and resuscitation systems as Class I, which is the agency’s highest-risk label. The Class I label means that exposure to the recalled device could lead to serious injury or death. The recall, which was initially issued last October, affected the following products:

• Giraffe Warmer with Resuscitation System
• Panda Warmer with Resuscitation System
• Giraffe Stand-Alone Infant Resuscitation System
• Resuscitation System Upgrade Kits
• Panda Freestanding with Resuscitation System

The machines are used to resuscitate infants and regulate body temperature. According to the FDA memo, the devices were recalled because some parts were assembled backwards. This could cause the systems to deliver too much or too little oxygen to newborns, leading to serious injury and possibly death. The agency said that infants at higher risk include those who are critically ill, premature and low-birth weight. The machines were manufactured between April 1, 2007 and October 31, 2013 and distributed from October 1, 2007 and October 31, 2013.

GE has had some safety issues with its neonatal systems in the past year. In February 2013, the company recalled its upgrade kits for some mislabeled infant warmers, which could lead to the delivery of inappropriate amounts of oxygen. The FDA also designated that recall as Class I due to risk of injury or death. Last April, a warning was also issued for certain Giraffe incubators and OmniBed systems. The company said that the systems had a faulty part that could cause the machines to forget its previous settings when turned off and then on, or in the case of power outage. This could lead to the patient getting inappropriate oxygen and temperature settings.