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U.S. Department of Health and Human Services

Class 2 Device Recall INOmax DSIR Delivery System

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  Class 2 Device Recall INOmax DSIR Delivery System see related information
Date Initiated by Firm March 27, 2014
Date Posted May 02, 2014
Recall Status1 Terminated 3 on November 21, 2014
Recall Number Z-1528-2014
Recall Event ID 67947
510(K)Number K131686  
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product 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.
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. 
Recalling Firm/
Manufacturer		 INO Therapeutics (dba Ikaria)
2902 Dairy Dr
Madison WI 53718-3809
For Additional Information Contact Customer Care
877-566-9466
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 22
Distribution Nationwide Distribution including DC and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRN and Original Applicant = INO THERAPEUTICS/IKARIA
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