# FDA recall Z-2796-2018

> **Hamilton Medical AG** · Class II · device recall initiated 2018-03-09.

## Product

Hamilton-C3 Ventilator Unit    Product Usage:  The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.

## Reason for recall

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

## Distribution

US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI.      Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

## Key facts

- **Recall number:** Z-2796-2018
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-09
- **Report date:** 2018-08-22
- **Termination date:** 2019-03-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2796-2018

## Citation

> AI Analytics. FDA recall Z-2796-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2796-2018. Source: US FDA. Licensed CC0.

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