Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0575-2015 — INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (

U.S. FDA — Device Enforcement · United States · 2014-10-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0575-2015
Date of alert: 2014-10-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: INO Therapeutics (dba Ikaria)
Product category: device
Product type: Devices

Reported risk: An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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