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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 62856
Product Type Devices
Status Ongoing
Recalling Firm Newport Medical Instruments Inc
City Costa Mesa
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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, Class I May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. 72 Z-2250-2012