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Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
The FDA is aware that Hamilton Medical AG has emailed all affected customers an Urgent Medical Device Correction letter regarding the HAMILTON-C6 ventilators due the possibility of certain ESM circuit boards having mechanical pre-damage from printed circuit board separation at the supplier. This defect can cause a short circuit that prevents startup or causes the ventilator to enter an ambient state during use, interrupting ventilation.
The use of affected product may cause serious adverse health consequences, including trouble breathing (respiratory failure), low blood oxygen (hypoxemia), damage to the brain or other organs, and death.
There have been no reported injuries or deaths related to this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Hamilton Medical AG (Vigilance Team) at fieldactions.med.global@hamiltonmedical.com.
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