Product Safety Recalls

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Hamilton Medical AG Recall 91925

Description: HAMILTON-C6, REF: 160021

Hamilton Medical AG Recall 91925 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1429-2023
Event ID91925
Event DescriptionHAMILTON-C6, REF: 160021
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Recall ReasonSoftware 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.
Device Classification20230503
Device Code InfoSoftware Version: 1.2.1, UDI-DI: 07630002808590
Center Classification Date20230425
Recall Initiation Date20230314
Recalling FirmHamilton Medical AG
Initial Notification Letter
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