| Hamilton Medical AG is recalling the HAMILTON-C6 Intensive Care Ventilator due to a hardware issue with the ventilator's status indicator board, which may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator's main board. This water ingress may cause the ventilator to revert to a safety ventilation mode or revert to an ambient state, which means the patient breathes ambient room air with no assistance or support from the machine. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. Questions? Customers with questions or concerns about this recall should contact Hamilton Medical AG at: +41 58 610 1020 or techsupport@hamilton-medical.com. | | | |
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