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Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with v...

FDA Device Recall #Z-1223-2015 — Class II — January 14, 2015

Recall Summary

Recall Number Z-1223-2015
Classification Class II — Moderate risk
Date Initiated January 14, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm INO Therapeutics (dba Ikaria)
Location Madison, WI
Product Type Devices
Quantity 45 units

Product Description

Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

Reason for Recall

Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.

Distribution Pattern

Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.

Lot / Code Information

Finished Product Serial#. DS20070005 DS20090559 DS20100326 DS20100343 DS20100915 DS20101282 DS20070101 DS20080024 DS20080064 DS20080074 DS20080141 DS20080222 DS20080229 DS20080318 DS20090052 DS20090086 DS20090109 DS20090121 DS20090190 DS20090328 DS20090584 DS20090611 DS20090618 DS20090676 DS20090708 DS20090770 DS20090825 DS20090880 DS20090890 DS20090931 DS20090941 DS20100016 DS20100038 DS20100283 DS20100285 DS20100302 DS20100497 DS20100529 DS20100542 DS20100665 DS20100724 DS20100747 DS20100851 DS20100852 DS20100887 DS20100939 DS20101073 DS20101077 DS20101264 DS20101330 DS20101397 DS20101505 DS20110021 DS20110204 DS20110353 DS20110388 DS20110398 DS20110399 DS20110406 DS20110429 DS20110433 DS20110487 DS20110850 DS20110867 DS20110934 DS20110967 DS20111009 DS20111123 DS20111124 DS20111125 DS20111140 DS20111184 DS20111185 DS20111190 DS20111206 DS20120019 DS20120167 DS20120172 DS20120191 DS20120197 DS20100219 DS20100877 DS20110787 DS20110410 DS20080298 DS20100012 DS20100162 DS20100962 DS20100964 DS20110892 DS20110981 DS20070010 DS20070255 DS20080314 DS20090265 DS20090424 DS20090642 DS20090661 DS20090889 DS20100036 DS20100583 DS20101157 DS20101214 DS20101478 DS20111200 DS20120041 DS20070041 DS20090013 DS20090028 DS20090034 DS20090647 DS20090923 DS20100395 DS20100443 DS20101226 DS20101314 DS20101396 DS20101482 DS20101523 DS20111029 DS20111057 DS20111091 DS20111120 DS20120047 DS20120049

Other Recalls from INO Therapeutics (dba Ikaria)

Recall # Classification Product Date
Z-1076-2017 Class II Mallinckrodt Pharmaceuticals INOmax DSIR Plus d... Nov 21, 2016
Z-0575-2015 Class II INOMAX DSIR Nitric Oxide delivery system, Model... Oct 17, 2014
Z-1528-2014 Class II INOmax DSIR, model 10007, Nitric Oxide Delivery... Mar 27, 2014

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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