Recall Z-1171-2013— Newport Medical Instruments Inc

Name: FDA recall Z-1171-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-05

Class I · Terminated

Class I FDA medical device recall by Newport Medical Instruments Inc, initiated 2013-04-05, terminated 2015-03-10. It names 2 FDA 510(k) clearances: K111146, K090888. Product: Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are 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.. Reason: Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery..

Recalling firm: Newport Medical Instruments Inc
Classification: Class I
Status: Terminated
Initiated: 2013-04-05
Terminated: 2015-03-10
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 Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are 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.

Reason for recall

Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

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