# FDA recall Z-1385-2022

> **Hamilton Medical AG** · Class III · device recall initiated 2021-01-05.

## Product

HAMILTON-H900 Humidifier, Models: 950001, 950004

## Reason for recall

When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

## Distribution

US: WI, FL, CA, NV, PA, TX, PA

## Key facts

- **Recall number:** Z-1385-2022
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class III
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-01-05
- **Report date:** 2022-07-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2022

## Citation

> AI Analytics. FDA recall Z-1385-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1385-2022. Source: US FDA. Licensed CC0.

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