The FDA resent information on January 31 regarding the October 15, 2012 voluntary field corrective action, initiated by GE Healthcare, for the field upgrade kit for GE Healthcare’s resuscitation systems with blender, installed in GE Giraffe and Panda infant warmers.
The field upgrade kit for GE Healthcare’s resuscitation unit with blender, used with GE’s Giraffe and Panda infant warmers, may impact patient safety. The oxygen and air wall inlet fittings and/or labels on the back panel may have been reversed during assembly. 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 affected resuscitation system upgrade kits were manufactured from April 2008 to September 2012. GE field service engineers have inspected units at approximately 89% of the identified customer sites. The remaining unconfirmed customers are being contacted and scheduled for inspection by GE field service technicians. To date, no patient injuries have been reported with this issue.
The FDA defines Class I Recalls as “a situation 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.”
View the FDA notice by clicking here.