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.
Enforcement
- Recall Number
- Z-1874-2017
- Event ID
- 76891
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Newport Medical Instruments Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 10, 2017
- Initiation Date
- March 30, 2017
- Classification Date
- May 1, 2017
- Termination Date
- July 18, 2020
- Address
- 1620 Sunflower Ave, Costa Mesa, CA, 92626-1513, United States
Description
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.
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.
All Newport Medical HT70 and HT70- Plus Ventilators
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, United Arab Emirates, United Kingdom Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana Bulgaria, Cyprus, Czech Republic, Denmark, Egypt, Finland, France Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon Lithuania, Macedonia, Malawi, Malta, Mauritius, Mozambique, Netherlands Norway, Oman, Poland, Portugal, Qatar, Republic of Moldova, Romania Saudi Arabia, Serbia, Slovakia, Sudan, Sweden, Switzerland, Tunisia Turkey, Uganda, Ukraine, United Kingdom, Yemen, and Zimbabwe
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