FDA Alerts

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 2013By Kaylee McCaffrey

 

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.

 

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