GE Nellcor SpO2 Upgrade kit Cl II

Company: GE Healthcare
Date of Enforcement Report:5/14/2014
Class lI:

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). Recall Number Z-1551-2014

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/MANUFACTURER
GE Healthcare, Laurel, MD on 4/2/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
301

DISTRIBUTION
Nationwide and Internationally

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