FDAFDA · Food and drugs·Recall number Z-1429-2023
HAMILTON-C6, REF: 160021
Published May 3, 2023 · Recall initiated: March 14, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hamilton Medical AG
- Distributor
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Lot
- Software Version: 1.2.1, UDI-DI: 07630002808590
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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