Agency classClass IIOur severity:High FDA (Devices)·Z-0913-2014·Announced 2014-02-12

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Hazard: inaccurate-gas-mixture
loose-knob
Affected units: 9,232

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 6 products in this recall →

Same manufacturer · GE Healthcare

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Same hazard · inaccurate gas mixture