GE Healthcare is ordering a recall of some of its resuscitation systems designed to deliver oxygen to newborns. The recall is due to a manufacturing error that may interfere with oxygen delivery and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). These are potentially deadly conditions for newborns, especially those who are critically ill and/or were born preterm or low birthweight.
The recall involves specific lot numbers of the following GE Healthcare products: Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, and Panda Freestanding with Resuscitation System.
These products are also referred to as: 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, and T-Piece Resuscitation System.
The affected products were manufactured from April 1, 2007 through Oct. 31, 2013, and distributed from Oct. 1, 2007, through Oct. 31, 2013.
In the affected products, oxygen and air inlet fittings were reversed during assembly. GE Healthcare sent a letter to its customers identifying the products, the problem and providing safety instructions to be taken by the customer along with the product correction.
The recall is classified as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Any adverse effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.