Noxboxi Nitric Oxide Monitor And Delivery System

Recalling firm
Keyport Ltd
Product
NOXBOXi Nitric Oxide Monitor and Delivery System. [Device]. Model: Product Code - NOXBOX-I. Affected: Serial number: NI103206, NI100931, NI101157, NI101195, NI103009, NI100792
Reason
The manufacturer has identified a manufacturing issue affecting certain oxygen sensors. The issue may cause oxygen sensors to intermittently display irregular oxygen concentrations or cause the NOxBOXi device to fail the required oxygen sensor zero calibration. This sensor failure may be, intermittent and may not be detected immediately following manufacture or during pre-use system and setup checks. Based on the design of the NOxBOXi device, the oxygen sensor is used solely to monitor the oxygen level in the sampled gas and is complimentary to other oxygen monitoring that might be used on...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-10-22
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/941b229d-1537-4f46-a225-619586d19164