The devices, originally recalled in October 2013, have components that were installed backwards during assembly. The error may result in devices delivering inaccurate levels of oxygen and may lead to over- or under-oxygenation that could cause infants injury or even death, FDA warned.
The affected devices were manufactured over a period of 3 years, between April 1, 2007, and October 31, 2013, according to the FDA memo. They were distributed from October 1, 2007, through October 31, 2013.
GE’s neonatal systems have been the subject of a couple of warning in the last year, including a February 2013 recall affecting upgrade kits for some infant warmers over mislabeling that could results in inappropriate oxygen delivery. The FDA also gave that measure, which was initially launched in October 2012, its highest-risk Class I label over concerns that the mistake could lead to injury or death.
GE also issued an April 2013 warning for certain Giraffe incubators and OmniBed systems, saying that some of the machines contained a faulty component that they may not "remember" their previous settings when turned off and then on or in case of power failure, reverting to default oxygen or temperature settings that may not be appropriate for the patient. Efforts to address that issue had begun in January 2013, GE said at the time.