Reported May 14, 2014 · Terminated
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system…
INO Therapeutics (dba Ikaria)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INO Therapeutics (dba Ikaria) · 2902 Dairy Dr · Madison, WI · 53718-3809
Is this the product you have?
- 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 primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
- Lot codes and dates
- Serial Numbers
DS20080152DS20090218DS20090243DS20090271DS20090523DS20090598DS20090821DS20090925DS20101022DS20101076DS20101147DS20101374DS20101413DS20101420DS20101499DS20101637DS20111199DS20120099DS20120150DS20120169DS20120288DS20120306
- Serial Numbers
- Amount recalled
- 22
Where it was sold
Why it was recalled
An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha
This product could cause temporary or reversible health problems — stop using it.
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