FDA-Device2013-02-06Class I
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
Hamilton Medical Inc
Hazard
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.
Sold states
US Nationwide Distribution including the country of Switzerland.
Affected count
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Manufactured in
4990 Energy Way, P O Box 30008, Reno, NV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2013Don't want to check this manually?
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