FDA Device recall Z-1874-2017
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide conti…
- FDA Device
- Class I
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class I recall of Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide conti… by Newport Medical Instruments, citing 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 operati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1874-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-03-30 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Newport Medical Instruments |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | All Newport Medical HT70 and HT70- Plus Ventilators |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1874-2017%22
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