Z-2020-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2024
- Initiation Date
- May 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68
Product Description
Ventilator HAMILTON-C6, PN: 160021
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 Pattern
US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
Code Information
UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6