GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect
GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect that could lead to missed or false alarms for critical vital signs (oxygen saturation and pulse rate), representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 301 units of the Nellcor SpO2 Upgrade kit, which consists of a circuit board and is an integral component of the Nellcor SpO2 device. These devices are used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and are also used to provide controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology.
The recall is being issued because the medical device software may be defective. This defect may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver.
The affected units were distributed worldwide. Consumers and healthcare facilities should stop using the affected devices and contact GE Healthcare for further instructions on how to resolve the issue.
The recalled product
- 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…
- Manufacturer
- GE Healthcare
- Affected units
- 301
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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