# FDA recall Z-2139-2023

> **Hamilton Medical, Inc.** · Class I · device recall initiated 2023-06-15.

## Product

HAMILTON C1 Ventilator REF   161001  1610010    Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

## Reason for recall

Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

## Distribution

U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming  Added 08/30/2023 - Puerto Rico  O.U.S.: Bahamas, Japan and Mexico

## Key facts

- **Recall number:** Z-2139-2023
- **Recalling firm:** Hamilton Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-15
- **Report date:** 2023-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reno, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2023

## Citation

> AI Analytics. FDA recall Z-2139-2023. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2139-2023. Source: US FDA. Licensed CC0.

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