FDA-Device2022-07-20Class III
HAMILTON-H900 Humidifier, Models: 950001, 950004
Hamilton Medical AG
Hazard
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Sold states
US: WI, FL, CA, NV, PA, TX, PA
Affected count
203
Manufactured in
Via Crusch 8, Bonaduz, Switzerland
Products
HAMILTON-H900 Humidifier, Models: 950001, 950004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2022Don't want to check this manually?
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