FDA Device recall Z-2250-2012
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus
- FDA Device
- Class I
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class I recall of Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus by Newport Medical Instruments, citing may emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Newport Medical Instruments |
| Distribution | US |
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.
Reason
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Identifiers
| code_info | Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236…Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2012%22
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