Hamilton Medical AG recalls Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to p…

Recall date

June 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2328-2025

FDA classification

Class I

Brand / firm

Hamilton Medical AG

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.