Device recall: INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system…
Class II FDA enforcement event 67947. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
INO Therapeutics (dba Ikaria) started this device recall on 27 Mar 2014. The firm address in the FDA record is in Madison, WI. FDA put the recall in Class II. FDA event 67947 has 1 product record. The first FDA enforcement report date is 14 May 2014. The record gives the status Terminated, with the termination date 21 Nov 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including DC and VA.
Recalling firm
INO Therapeutics (dba Ikaria), Madison, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1528-2014 | 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… | 22 | Class II | Terminated | 14 May 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Nov 2016 | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation | Device | Class II | 1 |
| 14 Jan 2015 | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. | Device | Class II | 1 |
| 17 Oct 2014 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhala | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1528-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67947. https://recallregister.com/fda/ii/67947/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including DC and VA.
- What quantity of product is in FDA event 67947?
- The FDA record gives this quantity:
22
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.