Z-0575-2015 Class II Terminated
FDA device recall Z-0575-2015 was initiated by INO Therapeutics (dba Ikaria) on October 17, 2014 and is designated Class II. Reason for recall: 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 manufact… The recall status is terminated (terminated April 16, 2015). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- October 17, 2014
- Termination Date
- April 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution in states of: VA and PA only.
Code Information
Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.