FDA recall Z-2328-2025

Hamilton Medical AG · Class I · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-06-03
Report date
2025-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Domat/Ems, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2328-2025