GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect
GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.
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 product (infant warmer/monitor) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 15 units of Panda Wall-Mount Infant Warmers, which are integrated with Nellcor SpO2 monitoring. These devices provide controlled infrared heat to neonates who cannot regulate their own body temperature and include a feature for continuous noninvasive monitoring of functional oxygen saturation and pulse rate.
The recall is due to a potential defect in the medical device software. This defect may cause user-set alarm limits to result in false positive or false negative alarm notifications for oxygen saturation and pulse rate, potentially misleading caregivers.
The affected units were distributed worldwide. The specific serial numbers for the recalled units are HDJS52856, HDJS52857, HDJS52858, HDJS52859, HDJS52860, HDJS52861, HDJS52862, HDJS52863, HDJS52864, HDJS52865, HDJS52800, HDJS52801, HDJS52802, HDJS52803, and HDJS52804. Healthcare facilities should contact GE Healthcare for instructions on how to address the software defect.
The recalled product
- Product
- Panda¿ Wall-Mount 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…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Infant Warmer
- Affected units
- 15
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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