# FDA recall Z-1429-2023

> **Hamilton Medical AG** · Class II · device recall initiated 2023-03-14.

## Product

HAMILTON-C6, REF: 160021

## Reason for recall

Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

## Distribution

US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

## Key facts

- **Recall number:** Z-1429-2023
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-14
- **Report date:** 2023-05-03

- **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-1429-2023

## Citation

> AI Analytics. FDA recall Z-1429-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1429-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*