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.
