Recall Z-2250-2012— Newport Medical Instruments Inc

Name: FDA recall Z-2250-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-03

Class I · Terminated

Class I FDA medical device recall by Newport Medical Instruments Inc, initiated 2012-08-03, terminated 2014-04-14. It names 2 FDA 510(k) clearances: K111146, K090888. 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..

Recalling firm: Newport Medical Instruments Inc
Classification: Class I
Status: Terminated
Initiated: 2012-08-03
Terminated: 2014-04-14
Firm location: Costa Mesa, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K111146 — NEWPORT HT70 VENTILATORNewport Medical Instruments, Inc.·cleared 2011-12-01
K090888 — NEWPORT HT70 FAMILY OF VENTILATORSNewport Medical Instruments, Inc.·cleared 2009-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.

Data sourced from openFDA. This site is unofficial and independent of the FDA.