Company:Hamilton Medical Inc.
Date of Enforcement Report 2/6/2013
Class l:
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. Recall Number Z-0741-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Hamilton Medical Inc., Reno NV on 1/11/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
DISTRIBUTION
Nationwide and country of Switzerland
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