Reported Jun 26, 2024 · Ongoing

Ventilator HAMILTON-C6, PN: 160021

Hamilton Medical AG

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical AG · Via Crusch 8 · Bonaduz, N/A · N/A

Is this the product you have?

  • Ventilator HAMILTON-C6
  • PN160021
Lot codes and dates
  • UDI07630002808590
  • Software Versions
    • SW v1.1.4
    • SW v1.1.5
    • SW v1.1.6
Amount recalled
68

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:22 PM UTC

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