INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system deliv
FDA device recall Z-1528-2014 · posted 2014-05-02 · Terminated
Recall details
- Recalling firm
- INO Therapeutics (dba Ikaria)
- 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
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 22
- Distribution
- Nationwide Distribution including DC and VA.
- Date initiated
- 2014-03-27
- Date posted
- 2014-05-02
- Date terminated
- 2014-11-21
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOMAX DSIR (DELIVERY SYSTEM) (K131686) | Ino Therapeutics/Ikaria | 2013-11-29 |