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Hamilton Medical Inc recalls HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide p
Recalled February 6, 2013 · FDA recall Z-0741-2013 · Hamilton Medical
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. · FDA Class I
Units
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Sold at
US Nationwide Distribution including the country of Switzerland.
Description
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.
Product
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
Manufacturer(s)
Hamilton Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →