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Recall Observatory FDA recall evidence

Device product

Ventilator HAMILTON-C6, PN: 160021

Z-2020-2024

May 15, 2024

Class I

Product summary

Firm
Hamilton Medical AG
Event
Event 94671
Status
Ongoing
Classification
Class I
Quantity
68
Official record key
device-enforcement:Z-2020-2024

Official wording

Reason: 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.

Code information: UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6

Distribution pattern: US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.