Company: Hamilton Medical AG
Date of Enforcement Report: 4/25/2023
Class II

PRODUCT

HAMILTON-C6, REF: 160021

Recall Number:

Z-1429-2023

REASON:

Software error causes, safety ventilation malfunction, 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

RECALLING FIRM/MANUFACTURER:

Hamilton Medical AG

VOLUME OF PRODUCT IN COMMERCE:

103

DISTRIBUTION:

US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.