GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (infant warmer/monitor) where the defect could lead to missed or false alarms, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 723 units of Panda iRes Infant Warmers integrated with Nellcor SpO2. These devices provide controlled infrared heat to neonates who are unable to thermo-regulate and include an integrated monitoring feature for continuous noninvasive monitoring of functional oxygen saturation and pulse rate.
The recall is due to a defect in the medical device software. This defect may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver. The affected units were distributed worldwide.
Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to GE Healthcare according to their instructions.
The recalled product
- Product
- 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…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Infant Warmer
- Affected units
- 723
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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