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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