GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.
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 where a software defect could lead to false alarms for critical vital signs in neonates. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
GE Healthcare is recalling 50 units of Giraffe Infant Warmers integrated with Nellcor SpO2. These devices provide controlled infrared heat to neonates who cannot regulate their own temperature and include a monitoring feature for continuous noninvasive tracking of functional oxygen saturation (SpO2) and pulse rate.
The recall is due to a potential software defect that may cause user-set alarm limits to result in false positive or false negative notifications for oxygen saturation and pulse rate. This could lead to incorrect alarm signals being sent to caregivers.
The affected units were distributed worldwide. Healthcare providers should stop using the affected devices and contact GE Healthcare for further instructions.
The recalled product
- Product
- Giraffe¿ 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…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Neonatal Care
- Affected units
- 50
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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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