Class 1 Recall: Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower
The HAMILTON-T1 ventilator provides continuous or intermittent breathing support to adults and pediatric patients.
Fri Jan 11 2013
Reason for Recall: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower. This may cause miscalculation of the required oxygen needed for long time applications with limited oxygen supply. The HAMILTON-T1 oxygen capacity must be calculated using a larger margin than originally expected.
This product may cause serious adverse health consequences, including death.