FDA issues Class 1 recall for Hamilton Medical ventilators

Hamilton Medical's G5 Ventilator--Courtesy of Hamilton

Ongoing issues that have dogged Hamilton Medical ventilators have triggered a second recall of the devices this year. This time the Swiss-based company is recalling 1,126 of the machines from U.S. healthcare providers.

The FDA notice released this week cites issues with the private company's Hamilton-G5 ventilator that can result in the unintentional suppression of ventilation alarms after the activation of a suctioning maneuver by the operator, regardless of whether the device is being used for neonatal, pediatric or adult patients.

A Class 1 recall is the most severe of the agency's categories, as exposure to such a classified device holds a "reasonable probability" of significant health consequences to a patient or death. The current recall covers the ventilators with software versions between V2.00 and 2.31.

The company notified the affected customers in April with a letter that identified the product, the problem and the action to be taken, the FDA said. However, the agency only disclosed the recall this week.

In June, the FDA posted a Class 2 recall notice for the Hamilton-G5 ventilators with software versions V2.40 and 2.41. That recall was based on customer reports that the ventilator display may freeze, causing the device to no longer operate and data to no longer be displayed on the screen.

The agency issued a Class 1 recall in 2013 for Hamilton-T1 ventilators with software versions 1.12 and lower due to software problems that could cause the miscalculation of the oxygen needed. In the last two years, ventilators made by CareFusion, Covidien and Philips Respironics have all been issued Class 1 recalls by the FDA.

Hamilton Medical was founded in 1983 and markets itself as a player in intelligent ventilation solutions with a particular focus on intensive care patients.

- here is the FDA recall announcement

Editor's Note: This article has been corrected to reflect the fact that the FDA downgraded its June recall to Class 2 after originally classifying it as Class 1.

 

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