GE Healthcare Panda Infant Warmers Recalled for Loose Adjustment Knob
GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate gas mixture) to vulnerable neonates without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 9,232 units of Panda iRes Infant Warmers (part number M1112198) and Panda Freestanding Warmers (part number 2063568). The recall is due to a potential defect where the medical device adjustment knob may be loose, which could affect the accuracy of the blended Air/Oxygen gas mixture provided to patients.
These devices are used to provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. The affected units were distributed worldwide, including in the United States (nationwide and Puerto Rico) and numerous international locations such as Canada, the United Kingdom, Germany, France, and Australia.
Healthcare facilities and consumers should check their devices against the list of affected serial numbers provided in the official recall notice. If a device is affected, it should be removed from service and returned to GE Healthcare for repair or replacement according to the company's instructions.
The recalled product
- Product
- Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Infant Warmer
- Affected units
- 9,232
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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