The FDA has issued a Class I recall for some of GE healthcare’s neonatal resuscitation devices after the company discovered life-threatening malfunctions.
Giraffe Warmer and Panda Warmer Resuscitation systems were designed to resuscitate infants and newborns it was also used to regulate body temperature.
However, on November 18th GE sent an urgent medical device correction letter to customers after discovering that the oxygen and air wall inlet fittings on the back panel of the systems were reversed during assembly which has interfered with the oxygen delivery.
How Dangerous Is the Error?
The FDA said in its recall that the error could lead to low or high blood oxygen and potentially death. GE says that the malfunction could reverse air and oxygen mixer concentrations, making certain settings inaccurate.
GE has been notifying customers since October through a letter that has been instructing hospital personnel how to inspect the device.
Though no patients have been injured the company said the field service engineers have been following up with the malfunction.
Neonatal Resuscitation: Class I Recall
The FDA has classified this neonatal resuscitation device recall as a Class I recall in which they define as a situation in where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
The recall includes the following models:
- 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
Class I recalls are the most serious type of recall.