# FDA recall Z-0449-2024

> **AURIS HEALTH INC** · Class II · device recall initiated 2023-10-18.

## Product

Monarch Platform  REF MON-000005-01R, 100-240V- 50/60Hz 1440w

## Reason for recall

Their is the potential that software issues  may result in flipped image of the virtual Bronchoscope view.

## Distribution

US Distribution: AK,	AL,	AZ,	CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.

## Key facts

- **Recall number:** Z-0449-2024
- **Recalling firm:** AURIS HEALTH INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-18
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redwood City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0449-2024

## Citation

> AI Analytics. FDA recall Z-0449-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0449-2024. Source: US FDA. Licensed CC0.

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