FDA-Device2022-11-30Class II
Hamilton-C6
Hamilton Medical AG
Hazard
Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
Sold states
U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.
Affected count
8,229 total systems worldwide (U.S. 443 systems)
Manufactured in
Parc Industrial Vial 10, N/A, Domat/Ems, N/A, Switzerland
Products
Hamilton-C6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2023Don't want to check this manually?
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