INOmax DSIR, model 10007, Nitric Oxide Delivery System… recallZ-1528-2014 · INO Therapeutics (dba Ikaria) · initiated Mar 27, 2014
Class II Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from INO Therapeutics (dba Ikaria) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Software Design Change
What the company is doing
Ikaria sent an Urgent Field Corrective Action letter via FedEx on March 27, 2014. The letter identified the issue, and requested that all INOmax DSIR with software version 3.0.0 be returned to Ikaria. Customers with questions were instructed to contact Ikaria Customer Care at 1-877-566-9466. For questions regarding this recall call 877-566-9466.
Recall details
- Recall number
- Z-1528-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 27, 2014
- Posted by the FDA
- May 2, 2014
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Quantity
- 22
- Product code
- MRN
- FDA submissions
- K131686
- Distribution
- Nationwide Distribution including DC and VA.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.
Other devices under the same FDA submission
1 device cleared under K131686 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INOmax DSIR Plus 10007Mallinckrodt Manufacturing LLC · Analyzer, nitrogen dioxide3 deaths713 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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