FDA-Device2012-09-12Class I
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medica
Newport Medical Instruments Inc
Hazard
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Sold states
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Affected count
72
Manufactured in
1620 Sunflower Ave, N/A, Costa Mesa, CA, United States
Products
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2012Don't want to check this manually?
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