Hamilton Medical Inc, Reno, Nev, has recalled the HAMILTON-T1 ventilators with software versions 1.1.2 and lower. It initiated the recall on January 11, 2013.
Manufactured and distributed from February 2012 through December 2012, the HAMILTON-T1 ventilator provides continuous or intermittent breathing support to adults and pediatric patients.
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 a 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.
Customers with questions may call the company at (800) 426-6331, ext 215.
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