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INO Therapeutics (dba Ikaria) Recalls
4 recalls on record · May 14, 2014 to February 1, 2017 · Medical Devices
Recalls by year
14
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17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 1, 2017Medical DevicesFDA
INO Therapeutics (dba Ikaria) recalls Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalati
Hazard: Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
March 11, 2015Medical DevicesFDA
INO Therapeutics (dba Ikaria) recalls Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Hazard: 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.
December 17, 2014Medical DevicesFDA
INO Therapeutics (dba Ikaria) recalls INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhala
Hazard: 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.
May 14, 2014Medical DevicesFDA
INO Therapeutics (dba Ikaria) recalls INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system deli
Hazard: 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