Z-1528-2014Class II

INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery...

Name: Z-1528-2014 INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery...
Creator: INO Therapeutics (dba Ikaria)
Published: 2014-03-27
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2014-03-27 / Terminated / root cause: software

FDA source

INO Therapeutics (dba Ikaria) began a recall of INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for... on 2014-03-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1528-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Posted: 2014-05-02
Terminated: 2014-11-21
Recalling firm: Mallinckrodt Manufacturing LLC
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 primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: 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
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 22
Distribution: Nationwide Distribution including DC and VA.
Product codes and lots: Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1528-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1528-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-02

Product code MRN

K131686Class IIInomax Dsir (Delivery System)Ino Therapeutics/Ikaria / cleared 2013-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)