FDA Device recall Z-1550-2014
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate base…
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate base… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1550-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-02 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
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
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.
Identifiers
| code_info | HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800…HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1550-2014%22
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