Hamilton recalls ventilators due to failure to restart

Hamilton Medical has recalled ventilators due to a potential failure to restart, as reported by the FDA. This issue can cause low blood oxygen, slow heart rate, and other serious health risks. There has been one injury and one death linked to this problem.

The recall is a correction, not requiring product removal. Users should check their devices for the affected software version and update their systems. The Hamilton-C6 ventilators, used in ICUs and other healthcare settings, are affected.

In May, Hamilton identified a software anomaly that may prevent the ventilator from restarting after an open suction procedure. Users can re-initiate ventilation by changing settings or restarting the device. The latest software version, 1.2.3, resolves this issue. Hamilton advises attaching their notification letter to the operator’s manual for older versions.

The FDA categorized this recall, affecting up to 68 devices, as a Class I event. Another Class I recall occurred in 2022 due to water ingress issues.