September 1, 2022

FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious.

The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may cause breathing support to stop.

To date, there have been 128 complaints (worldwide), no injuries, and no deaths associated with this issue.

Distribution dates were August31, 2017, to May 20, 2022.


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