Z-1528-2014 Class II Terminated
FDA device recall Z-1528-2014 was initiated by INO Therapeutics (dba Ikaria) on March 27, 2014 and is designated Class II. 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 intende… The recall status is terminated (terminated November 21, 2014). Affected quantity: 22.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- March 27, 2014
- Termination Date
- November 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
Product Description
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 transport of neonates.
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
Distribution Pattern
Nationwide Distribution including DC and VA.
Code Information
Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.