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Z-1874-2017 Class I Terminated

Recalled by Newport Medical Instruments Inc — Costa Mesa, CA

FDA device recall Z-1874-2017 was initiated by Newport Medical Instruments Inc on March 30, 2017 and is designated Class I. Reason for recall: 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 accompa… The recall status is terminated (terminated July 18, 2020). Affected quantity: 12,966.

Recall Details

Product Type: Devices
Report Date: May 10, 2017
Initiation Date: March 30, 2017
Termination Date: July 18, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,966

Product 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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

All Newport Medical HT70 and HT70- Plus Ventilators