GE Resuscitation System Recall Issued Due to Infant Death Risk
A recall of Giraffe and Panda brand name resuscitation systems has been reclassified to a Class I recall, after the manufacturer recognized the oxygen and air inlet fittings were reversed during assembly, posing an interference with oxygen delivery to infants and newborns that may cause serious adverse health consequences including death.
The GE Healthcare resuscitation systems recall was initially announced on October 1, 2013, but the FDA designated the action as a Class I recall on February 28. Problems with the systems may cause infants to receive too much or too little oxygen, posing a reasonable probability of serious injury or death.
The Giraffe and Panda resuscitation systems are devices used to resuscitate infants and newborns and regulate body temperature.
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According to information released by the manufacturer, an error during the assembly process may have resulted in the oxygen and air inlet fittings on the back of the resuscitation systems being reversed. This could result in an inaccurate delivery of oxygen to newborns that require heightened or decreased oxygen level treatment. In the event the infants receive incorrect levels of oxygen it may cause death, particularly to those who are critically ill, preterm, or had low birth weight.
The recall includes Giraffe Warmer Resuscitation Systems, Panda Warmer with Resuscitation Systems, Giraffe Stand-Alone Infant Resuscitation Systems, Resuscitation System Upgrade Kits, and Panda Freestanding with Resuscitation Systems. The devices were manufactured by GE Healthcare of Wauwatosa, Wisconsin from April 1, 2007 through October 31, 2013, where they were distributed for sale from October 1, 2007 through October 31, 2013.
Class I recalls are considered the most dangerous because there is a reasonable probability that the use of the recalled item will cause serious adverse health consequences including death.
GE Healthcare sent an Urgent Medical Device Correction letter to all known users on November 18, 2013, that identified the recalled products, the problem, safety instructions, and a return receipt.
GE has encouraged owners to check the recalled product codes to verify if their resuscitation system is affected and to warn all potential users of the safety notification and recommended actions sent in the Urgent Medical Device Correction letter. Customers may contact GE Healthcare for return instructions or general questions at 1-800-345-2700.
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