# FDA recall Z-2020-2024

> **Hamilton Medical AG** · Class I · device recall initiated 2024-05-15.

## Product

Ventilator HAMILTON-C6, PN: 160021

## Reason for recall

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

## Distribution

US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.

## Key facts

- **Recall number:** Z-2020-2024
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-15
- **Report date:** 2024-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bonaduz, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2024

## Citation

> AI Analytics. FDA recall Z-2020-2024. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2020-2024. Source: US FDA. Licensed CC0.

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