Hamilton Medical recalls ventilation systems over software issue

February 8, 2013 by MassDevice staff

Hamilton Medical recalled certain lots of its Hamilton-T1 ventilation systems over concerns that a "miscalculation" in oxygen consumption could harm pediatric patients.

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Swiss ventilation devices maker Hamilton Medical recalled certain of its Hamilton-T1 ventilators over concerns that a software glitch may harm pediatric patients.

The FDA gave the recall Class I status, a category reserved for device malfunctions "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

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The recall affects Hamilton-TI ventilators that run software versions 1.1.2 and lower, which were manufactured and distributed from February 2012 through December 2012, according to the FDA notice.

"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," according to the warning. "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."

Hamilton Medical is working on new software and the company plans to make arrangements with customers to swap out any affected ventilation systems with loaners while the defective ones are shipped to a service facility for an update.