Recall Z-1528-2014 ยท MRN Apparatus, Nitric Oxide Delivery
INO Therapeutics (dba Ikaria)
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
| Date | May 2, 2014 (initiated Mar 27, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 22 |
| Distribution | Nationwide Distribution including DC and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics/Ikaria, Nov 29, 2013 |