The FDA gave Class I status to GE Healthcare’s (NYSE:GE)
The recall affects field upgrade kits for the company’s resuscitation systems with blender, which are installed in GE Giraffe and Panda infant warmers, the company reported.
“The oxygen and air wall inlet fittings and/or labels on the back panel may have been reversed during assembly,” according to a statement. “As a result, this could potentially reverse the air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. The settings of the blender knob would no longer be accurate.”
The FDA’s Class I recall status applied to situations in which “there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”
GE began notifying customers of the issue in October 2012. GE service engineers have already inspected about 89% of
