Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared Recalled by GE Healthcare Due to Medical device software may be defective and may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare directly.
Affected Products
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Quantity: 723 units
Why Was This Recalled?
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Where Was This Sold?
Worldwide Distribution.
About GE Healthcare
GE Healthcare has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report