July 16, 2019

FDA: Class I recall of Hamilton–G5 Ventilators

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on July 12 identified the recall by Hamilton Medical AG (Bonaduz, Switzerland) of its Hamilton-G5 Ventilators as Class I, the most serious.

The recall was initiated because of a software failure that stops the ventilators after displaying an error message, leaving patients to breathe unassisted with ambient air. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

The company has received 14 complaints about the error message. There have been no reports of patient injury or death related to this issue.

The ventilators were manufactured between November 29, 2007, and October 31, 2018.

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