# FDA recall Z-1525-2022

> **Hamilton Medical AG** · Class I · device recall initiated 2022-06-27.

## Product

HAMILTON-C6 Intensive Care Ventilator, REF: 160021

## Reason for recall

Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed

## Distribution

US nationwide distribution including Puerto Rico.

## Key facts

- **Recall number:** Z-1525-2022
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-27
- **Report date:** 2022-08-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2022

## Citation

> AI Analytics. FDA recall Z-1525-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1525-2022. Source: US FDA. Licensed CC0.

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