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Newport Medical Instruments Inc recalls Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system
Recalled September 12, 2012 · FDA recall Z-2250-2012 · Newport Medical Instruments
Hazard
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. · FDA Class I
Units
72
Sold at
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Description
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Product
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.
Manufacturer(s)
Newport Medical Instruments Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →