GE Healthcare Resuscitation Systems: Class I Recall
MedSun: Newsletter #93, March 2014
FDA MedWatch Safety Alert
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
The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in newborns, and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). On November 18, 2013 GE Healthcare sent an Urgent Medical Device Correction letter, with a return receipt, to all affected customers.
GE Healthcare Resuscitation Systems: Class I Recall. FDA MedWatch Safety Alert. February 28, 2014.