FDA Medical Device Recalls (openFDA)
INO Therapeutics (dba Ikaria): INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
- Recall number
- Z-0575-2015
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Product
- INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
- Status
- Terminated
- Initiated
- 2014-10-17
- Posted
- 2014-12-12
- Terminated
- 2015-04-16
- Reason
- An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
- Root cause
- Process change control
- Action
- Ikaria contacted consignees by phone beginning 10/17/2014. A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.
- Quantity
- 9
- Distribution
- US Distribution in states of: VA and PA only.
- Lot, serial or model codes
- Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.
- 510(k) numbers
- ["K131686"]
- PMA numbers
- not on file
- Product code
- MRN
- Firm FEI
- 3004531588
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28