Newport Medical Instruments Inc recalls Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is inten…

Recall date

March 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1874-2017

FDA classification

Class I

Brand / firm

Newport Medical Instruments Inc

Sold / distributed

Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, Qatar, Romania, Russian Federation South Africa, Spain, Turkey, U…

Why it was recalled

Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators 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 Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.