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# Alert on GE HealthCare Infant Resuscitation Systems
- URL: https://www.fdaweb.com/alert-on-ge-healthcare-infant-resuscitation-systems/
- Published: 2026-06-08T12:00:00.000Z
- Updated: 2026-09-14T13:40:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161271

FDA has issued an [early alert ](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-infant-resuscitation-system-issue-ge-healthcare?ref=fdaweb.com)warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufactured by GE HealthCare, citing concerns that the devices may deliver incorrect oxygen concentrations to newborn patients. The alert follows a company notice advising users to inspect and, if necessary, remove affected infant resuscitation systems from service until corrective actions can be completed.

The issue involves an air-oxygen blender component, model M1091607-R, used in several infant warming and resuscitation systems, including the Giraffe6 Stand-Alone Infant Resuscitation System, Giraffe6 Warmer with Integrated Resuscitation System, Panda Warmer with Integrated Resuscitation System, and Panda Freestanding Warmer.

According to GE HealthCare, the shaft of the blender control knob can loosen over time, potentially causing the device to deliver oxygen concentrations that differ from those selected by clinicians. The malfunction could expose infants to either insufficient oxygen levels (hypoxia) or excessive oxygen levels (hyperoxia), both of which can result in serious clinical complications in vulnerable neonatal patients.

FDA said healthcare facilities should identify affected devices and remove them from patient use pending correction. If an affected device must remain in service before repairs are completed, users should follow enhanced inspection and testing procedures outlined by the manufacturer, including oxygen concentration verification and additional pre-use checks.

GE HealthCare also instructed customers to quarantine affected replacement blender inventory and contact company service representatives to arrange corrective action.

The affected systems are used in neonatal care settings to provide pulmonary resuscitation for infants by delivering oxygen or oxygen-air mixtures during manual ventilation.