Hamilton Medical AG 2023-05-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1429-2023
HAMILTON-C6, REF: 160021 Recall
Issued May 3, 2023 · Hamilton Medical AG
In May 2023, Hamilton Medical AG recalled the HAMILTON-C6, REF: 160021, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using HAMILTON-C6, REF: 160021 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Hamilton Medical AG to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Hamilton Medical AG
- Category
- Health
- Recall date
- May 3, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Recall number
- FDA-Z-1429-2023
- Made in
- Switzerland
- Issuing agency
- FDA
In context
- Hamilton Medical AG has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.