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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.

FDA Recall Z-2250-2012 · Posted 2014-04-14

Recalling FirmNewport Medical Instruments Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2012-08-03
Date Terminated2014-04-14
Product Quantity72

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.

Firm 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.".

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111146NEWPORT HT70 VENTILATORNewport Medical Instruments, Inc. · 2011-12-01K090888NEWPORT HT70 FAMILY OF VENTILATORSNewport Medical Instruments, Inc. · 2009-11-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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