Medical Device Recall: Ventilator HAMILTON-C6, PN: 160021
Hamilton Medical AG · May 15, 2024
Reason for Recall
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
Distribution
US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
States Affected
NATIONWIDE
Quantity Affected
68
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2020-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.