GE Neonatal Systems Issued Class I RecallMar 7, 2014
The U.S. Food and Drug Administration (FDA) has put their most serious recall label on GE’s Giraffe and Panda neonatal infant warmers and resuscitation systems. The “Class I” designation is used for recalled devices where there is risk of serious injury or death. The recall was initially issued last October, and 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
According to the FDA’s memo, the recall was issued because some parts were assembled backwards. This might cause the products to deliver too much or too little oxygen to newborns, which can lead to injury and even death. Critically ill, premature and low-birth weight babies are most at risk, the FDA said. The devices, which are used to resuscitate infants and regulate body temperature, were manufactured between April 1, 2007 and October 31, 2013. They were distributed from October 1, 2007 and October 31, 2013.
There have been several safety concerns over GE’s neonatal systems in the last year. In February 2013, the company also recalled its upgrade kits for some infant warmers due to mislabeling that could lead to inaccurate amounts of oxygen. The FDA also designated that recall as Class I due to risk of injury or death. Last April, a warning was issued for certain Giraffe incubators and OmniBed systems. The company said that the machines had a problem that may cause them to revert to default oxygen or temperature settings when turned off and then on, leading to inappropriate conditions for the patient.