Hamilton Medical, a ventilation device manufacturer based in Switzerland, announced that it had received Class I recall status from the United States Food and Drug Administration for its Hamilton-T1 ventilators. According to an FDA notice, the Class I recall is due to a software glitch that could be harmful or fatal to pediatric patients.

The recall impacts some Hamilton-TI ventilators that were manufactured between February and December of 2012.

In the FDA notice, the company stated, “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."

The FDA warning also stated that this combination of factors could lead to the miscalculation of a patient’s required oxygen. In particular, patients who require oxygen for a long time period may experience a limited supply of oxygen. The company stated that the Hamilton-T1 oxygen capacity will have to be calculated using a larger margin than originally anticipated.

According to Hamilton Medical, a new software update should solve all problems with the system. In addition, the company stated that it will loan out ventilation systems while defective ones are being updated.

References

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm338627.htm