FDA-Device2023-05-03Class II
HAMILTON-C6, REF: 160021
Hamilton Medical AG
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Affected count
103
Manufactured in
Via Crusch 8, N/A, Bonaduz, N/A, Switzerland
Products
HAMILTON-C6, REF: 160021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2023Don't want to check this manually?
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