Reported May 3, 2023 · Ongoing

HAMILTON-C6, REF: 160021

Hamilton Medical AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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?

  • HAMILTON-C6
  • REF160021
Lot codes and dates
  • Software Version1.2.1
  • UDI-DI07630002808590
Amount recalled
103

Where it was sold

Why it was recalled

Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

This product could cause temporary or reversible health problems — stop using it.

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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, 3:21 PM UTC

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