The Recall Desk
HighFDA (Devices)·Z-1528-2014·Announced 2014-05-14

INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly

INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.

What this means for you

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, and the hazard involves a monitoring system anomaly in a critical care device (NICU) that could lead to unintended alarms, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

INO Therapeutics (dba Ikaria) is recalling 22 units of the INOmax DSIR, model 10007, Nitric Oxide Delivery System with Software version 3.0.0. The affected devices are distributed nationwide, including DC and VA. The primary targeted clinical setting for these devices is the Neonatal Intensive Care Unit (NICU), with secondary use in the transport of neonates.

The recall is due to an anomaly in the monitoring system. When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm occurs. Additionally, an unintended NO2 cell failure alarm may also occur. These alarms are caused by an average NO/NO2 circuit concentration greater than the threshold, though the specific threshold value is not detailed in the provided source text.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. The specific serial numbers are: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, and DS20120306. Users should contact the recalling firm for instructions on remediation.

The recalled product

Product
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The prim
Manufacturer
INO Therapeutics (dba Ikaria)
Category
Medical Device — Respiratory / Gas Delivery
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: DS20080152
  • DS20090218
  • DS20090243
  • DS20090271
  • DS20090523
  • DS20090598
  • DS20090821
  • DS20090925
  • DS20101022
  • DS20101076
  • DS20101147
  • DS20101374
  • DS20101413
  • DS20101420
  • DS20101499
  • DS20101637
  • DS20111199
  • DS20120099
  • DS20120150
  • DS20120169

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · INO Therapeutics (dba Ikaria)

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