FDA Enforcement
Class II
Terminated
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).
Recall: Z-1550-2014
·
Reported May 14, 2014
Enforcement
- Recall Number
- Z-1550-2014
- Event ID
- 68067
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Healthcare
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 14, 2014
- Initiation Date
- April 2, 2014
- Classification Date
- May 6, 2014
- Termination Date
- May 11, 2016
- Address
- 8880 Gorman Rd, N/A, Laurel, MD, 20723-5800, United States
Description
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.
Code Info
HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804
Distribution
Worldwide Distribution.
Quantity
15 units