NIOX

Circassia AB · Model VERO Handle · UDI-DI 07350047030175

MXA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The NIOX VERO is supplied with an exchangeable handle accessory, to which the patient filter is attached and contains the NO scrubber filter. The handle should be exchanged by the user every 1000 measurement or after one year of use.

Recalls

Date	Firm	Reason
2021-02-26	CAIRE DIAGNOSTICS INC	Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.