Newport Medical Instruments Inc: 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 number

Z-2250-2012

Recalling firm

Newport Medical Instruments Inc

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.

Status

Terminated

Initiated

2012-08-03

Posted

2014-04-14

Terminated

2014-04-14

Reason

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

Root cause

Nonconforming Material/Component

Action

Newport Medical sent an Urgent Field Correction Notice letter dated August 3, 2012 to all affected customers, via DHL and FedEx courier services. The letter identified the affected product, reason for recall and actions to be taken. Customers were instructed to immediately stop using the affected ventilator and retrieve the replacement kit provided free of charge. In addition, the letter states that if the product was further distributed, to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Replacement form as replacements are completed. For questions contact Newport Medical Technical Support Department at 800-451-3111, extension 282, for U.S. customers; 714-427-5811, extension 500, for international customers.".

Quantity

72

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

["K090888","K111146"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2023050

Firm city

Costa Mesa

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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