Hamilton Medical Inc. has recently initiated a Class I recall—the most severe category—for certain models of their ventilators. The U.S. Food and Drug Administration (FDA) has highlighted this recall due to the potential to cause severe injuries or even fatalities.
Recalled Products and Details
The recalled products are the Hamilton-C1, C2, C3, and T1 ventilators, specifically those running on software versions lower than certain thresholds. The ventilators were distributed between Dec. 10, 2010, and May 1, 2023. A total of 21,429 devices in the U.S. are subject to this recall.
The recall stems from reports of a critical software glitch that could lead to the ventilators abruptly stopping their operation without any prior indication. This malfunction occurs if the device operates continuously for more than 91 days without a restart. During this unintended stoppage, the ventilator triggers an alarm and displays a technical fault on its screen, entering an ‘Ambient State.’
Patients who are incapable of breathing autonomously or don’t receive immediate attention could face severe health consequences, even risking their lives. As of now, however, there haven’t been any reported injuries or fatalities associated with this issue.
Hamilton Medical officials say they have communicated directly with affected customers, urging them to take immediate action. They’ve advised users to provide alternate ventilation promptly, turn off the ventilator’s power to exit the ‘Ambient State’, and arrange for servicing. Following service and safety checks, the ventilators can be returned to active use.