Recall Z-1551-2014— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2014-04-02, terminated 2016-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. 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..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-02
- Terminated
- 2016-05-11
- Firm location
- Laurel, MD, United States
Product description
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.