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Field Correction Action Issued for Resuscitation Systems Installed in GE Giraffe/Panda Infant Warmers Due to Potentially Deadly Oxygen Flow Errors


GE Healthcare initiated a voluntary field corrective action of 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.

 

This voluntary field correction only impacts field upgrade kits for GE Healthcare’s resuscitation systems with blender, installed in GE’ Giraffe and Panda infant warmers. 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 customers are being contacted and scheduled for inspection by GE field service technicians.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

 

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