Panda¿ Wall-Mount Infant Warmers — Class II medical device recall Z-1550-2014
Terminated recall by GE Healthcare, reported 2014-05-14. Medical device software may be defective and may cause user-set alarm limits to result in false positive or fa
| Recall number | Z-1550-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Laurel, MD, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2016-05-11 |
| Quantity | 15 units |
| Reason classes | software |
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 of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1550-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.