Class II — AURIS HEALTH INC
| Recalling firm | Auris Health, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. |
| Product | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w |
| Quantity | 110 units In total |
| 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. |
| Initiated | 2023-10-18 |
| Classified | 2023-12-01 |
| Recall number | Z-0450-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AURIS HEALTH INC (Z-0450-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93320/
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