If the company’s C1, C2, C3 and T1 ventilators are used for more than 91 days without restarting, they pose a risk of switching to an “Ambient State.” The FDA classified the recall as Class I, the most serious type, because the problem could result in serious injury or death.
As of Aug. 30, Hamilton has reported 80 complaints and zero injuries or deaths related to the recall.
Healthcare professionals are instructed to provide alternative ventilation immediately.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.