BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-2250-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2250-2012
    Event ID
    62856
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Newport Medical Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2012
    Initiation Date
    August 3, 2012
    Classification Date
    August 31, 2012
    Termination Date
    April 14, 2014
    Address
    1620 Sunflower Ave, N/A, Costa Mesa, CA, 92626-1513, United States

    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

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

    Code Info

    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,

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.

    Quantity

    72