Recall: Infant Resuscitation Systems

The oxygen and air wall inlet fittings on the back panel of certain GE Healthcare Resuscitation Systems were reversed during assembly, which may interfere with oxygen delivery.  This may may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia which may cause death in infants.  Critically ill, preterm, and low-birth weight babies are at increased risk.  The affected products include 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.
  

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products.  Click here to get help and for the FDA voluntary reporting form. Source: FDA.gov.

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