Panda¿ Wall-Mount Infant Warmers recall: Software Issue
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their…
Why was Panda¿ Wall-Mount Infant Warmers recalled?
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804
- Product
- Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their…
- Recalling firm
- GE Healthcare
- Quantity
- 15 units
- Distribution
- Worldwide Distribution.
- Recall date
- May 14, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)