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Hamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Recalled June 26, 2024 · FDA recall Z-2020-2024 · Hamilton Medical AG
Hazard
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. · FDA Class I
Units
68
Sold at
US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
Description
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.
Product
Ventilator HAMILTON-C6, PN: 160021
Manufacturer(s)
Hamilton Medical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →