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Hamilton Medical AG recalls HAMILTON-C6, REF: 160021
Recalled May 3, 2023 · FDA recall Z-1429-2023 · 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. · FDA Class II
Units
103
Sold at
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Description
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.
Product
HAMILTON-C6, REF: 160021
Manufacturer(s)
Hamilton Medical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →