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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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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
Distribution Pattern US Nationwide Distribution including the country of Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Software Versions 1.1.2 and below; Part numbers 161005, 161006. Class I 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. 97 total ventilators; 69 of part number 161005 and 28 of part number 161006 Z-0741-2013