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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Recall Number Z-0741-2013
Classification Class I
Code Info Software Versions 1.1.2 and below; Part numbers 161005, 161006.
Product Distributed Qty 97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Reason For Recall Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.

Event Detail

Event Id 64117
Product Type Devices
Status Ongoing
Recalling Firm Hamilton Medical Inc
City Reno
State NV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution including the country of Switzerland.
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