The FDA has issued an early alert after GE HealthCare told customers on 8 May to inspect or remove certain Giraffe6 and Panda infant resuscitation systems with air‑oxygen blenders. A blender component can loosen and change the delivered oxygen concentration, risking under‑ or over‑oxygenation of infants. GE recommends inspection, multipoint oxygen checks, removal of failing units, and frequent verification with an independent oxygen analyser until repairs are made. No serious injuries or deaths were reported as of 20 May; the alert follows a 2019 Class 1 recall affecting 25,204 devices.
FDA Issues Early Alert Over Blender Fault in GE HealthCare Giraffe6 and Panda Infant Resuscitation Systems
The US Food and Drug Administration (FDA) has issued an early alert about a potentially high‑risk fault affecting certain GE HealthCare infant resuscitation systems and warmers. The alert follows a customer letter from GE HealthCare advising inspection or removal of specific units that include air‑oxygen blenders.
What Happened
In a letter dated 8 May, GE HealthCare told customers that some Giraffe6 and Panda branded infant resuscitation and warmer systems equipped with air‑oxygen blenders should be inspected prior to use or taken out of service. The FDA’s early alert calls attention to GE HealthCare’s findings about a component in the blender assembly that can become loose.
Risk To Patients
The blender mixes ambient air and oxygen to deliver a controlled oxygen concentration during neonatal pulmonary resuscitation. If the blender component loosens, the device may deliver an oxygen concentration that differs from the clinician’s selected setting—potentially delivering too little or too much oxygen to an infant.
Clinical Guidance
GE HealthCare and the FDA advise the following actions for units that remain in use until corrected:
Inspect systems for visible damage and specifically check the air‑oxygen blender assembly.
Perform the multipoint oxygen concentration checks as described in the system user manual before each use where practical.
Withdraw any unit that fails inspection or the multipoint oxygen checks from patient care and contact a GE HealthCare sales or service representative.
Verify oxygen concentration frequently with an independent oxygen analyser until the unit has been repaired or replaced.
Status And Background
As of 20 May, GE HealthCare reported no known serious injuries or deaths linked to this issue. This alert follows prior scrutiny of the Giraffe and Panda product ranges: in 2019 GE HealthCare initiated a Class 1 voluntary recall of Giraffe and Panda i‑Res Infant Warmers due to side panels and latches that could crack or open. That recall affected 25,204 devices manufactured and sold in the United States since 2007.
Source: Medical Device Network (GlobalData). This article is provided for informational purposes and is not a substitute for formal clinical guidance or manufacturer instructions. Clinicians should follow device manufacturer and institutional policies and obtain professional advice when required.
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