HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator i...
FDA Recall #Z-0741-2013 — Class I — December 19, 2012
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
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.
Recalling Firm
Hamilton Medical Inc — Reno, NV
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Distribution
US Nationwide Distribution including the country of Switzerland.
Code Information
Software Versions 1.1.2 and below; Part numbers 161005, 161006.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated