FDA recall Z-1429-2023

Product

HAMILTON-C6, REF: 160021

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-03-14

Report date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bonaduz, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2023