FDA-Device2025-08-27Class I
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Hamilton Medical AG
Hazard
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
Sold states
US Nationwide distribution.
Affected count
1040 systems
Manufactured in
Parc Industrial Vial 10, N/A, Domat/Ems, N/A, Switzerland
Products
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2328-2025Don't want to check this manually?
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