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Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart
Hamilton Medical is correcting software for the HAMILTON-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the United States with questions about this recall should contact their local distribution partner or Hamilton Medical AG Technical Support by email at techsupport@hamilton-medical.com.
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