FDA-Device2025-10-15Class I
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Hazard
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Sold states
Domestic: TN;
Affected count
1667 units
Manufactured in
Unit 1, Eurolink Gateway; Castle Road, Sittingbourne, United Kingdom
Products
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2026Want us to check the next one for you?
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