March 3, 2014 — GE Healthcare and the U.S. Food and Drug Administration (FDA) have issued a Class I recall for Panda and Giraffe brand infant resuscitation systems because they may deliver an inappropriate amount of oxygen, which could cause death, especially in premature or critically ill infants.
The resuscitation devices are designed to establish a clear airway and provide pulmonary resuscitation for babies with oxygen or air/oxygen mixtures. The Panda and Giraffe Warmers also provide controlled warmth for infants who cannot regulate their body temperature.
The problem is that the air wall inlet and oxygen fittings were reversed during assembly. This might cause an infant to receive too much oxygen (hyperoxia) or too little (hypoxia), which could be fatal.
GE sold at least 12,300 resuscitation systems between October 2007 and October 2013. In November 2013, they sent customers an Urgent Medical Device Correction letter outlining the problem and corrective steps. Customers who have questions or concerns can contact GE at 1-800-345-2700, Monday – Friday, 8:00 am – 4:30 pm.
GE Resuscitation System recall includes:
- 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
- Giraffe Warmer
- Panda Warmer
- Panda iRes Warmer
- Giraffe and Panda IRes Infant Warmer
- Giraffe and Panda Bag and Mask Resuscitation System
- Giraffe and Panda Warmer TPiece
- T-Piece Resuscitation System
Do I have a GE Panda / Giraffe Warmer Lawsuit?
The Schmidt Firm, PLLC is currently accepting GE resuscitation system induced injury cases in all 50 states. If your child or somebody you know has been injured by a defective Panda Warmer, Giraffe Warmer, or other resuscitation system, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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