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Recall Observatory FDA recall evidence

Device 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).

Z-1550-2014

April 02, 2014

Class II

Product summary

Firm
GE Healthcare
Event
Event 68067
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-1550-2014

Official wording

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.

Code information: HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software may be defective and may cause user-set alarm limits to result in