Devices

Device Recall INOmax DSIR Delivery System

Model / Serial
Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including DC and VA.
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.
Manufacturer
INO Therapeutics (dba Ikaria)
1 Event
- Recall of Device Recall INOmax DSIR Delivery System

Manufacturer

INO Therapeutics (dba Ikaria)

Manufacturer Address
INO Therapeutics (dba Ikaria), 2902 Dairy Dr, Madison WI 53718-3809
Manufacturer Parent Company (2017)
Mallinckrodt Plc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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