Giraffe¿ 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).
Enforcement
- Recall Number
- Z-1547-2014
- 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
Giraffe¿ 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).
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.
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Worldwide Distribution.
50 units