|Hamilton Medical is recalling its T1 ventilators over a software glitch.--Courtesy of Hamilton Medical|
Hamilton Medical is recalling models of its T1 ventilators over a software glitch that can miscalculate how much oxygen the unit is using, and the FDA has given it a Class I tag, warning of serious injury or death.
The problem crops up when the device is used to treat small pediatric patients with high airway resistance and low lung function, according to the FDA. In models with certain software versions, the device uses an unexpectedly high amount of oxygen internally, throwing off calculations of how much is needed for long-term applications and putting patients at risk of ventilation failure.
Hamilton informed customers back in January, and the company is providing loaner units to affected clients while it takes the old ones to its Nevada service center and updates the software.
The company hasn't reported any adverse reactions, but the FDA is asking patients and physicians to disclose any and all related problems through its online MedWatch program.
- here's the FDA's note