GE Healthcare Recalls Giraffe Infant Warmers Due to Loose Adjustment Knob
GE Healthcare is recalling 1,970 Giraffe 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 involves a medical device used for neonates where a defect could affect the accuracy of the Air/Oxygen gas mixture. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 1,970 units of Giraffe Infant Warmers, part number M1118179. These devices provide infrared heat to neonates who are unable to thermoregulate based on their own physiology.
The recall is being issued because the medical device adjustment knob may be loose, which can affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients. The affected units were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. Consumers and medical professionals should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Infant Warmer
- Affected units
- 1,970
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.
See all 6 products in this recall →Related recalls
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