# FDA recall Z-2328-2025

> **Hamilton Medical AG** · Class I · device recall initiated 2025-06-03.

## 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

- **Recall number:** Z-2328-2025
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2328-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2328-2025. Source: US FDA. Licensed CC0.

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