25
Apr
2023

Recall: Software Error Causes Safety Ventilation Malfunction

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0

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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