FDAFDA · Food and drugs·Recall number Z-2020-2024
Ventilator HAMILTON-C6, PN: 160021
Published June 26, 2024 · Recall initiated: May 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hamilton Medical AG
- Distributor
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
- Lot
- UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- Switzerland
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