Monarch Platform REF MON-000005-01 — Class II medical device recall Z-0448-2024
Ongoing recall by AURIS HEALTH INC, reported 2023-12-13, distributed in AK, AL, AZ, CA, CO, CT, DC, DE…. Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
| Recall number | Z-0448-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AURIS HEALTH INC, Redwood City, CA, United States |
| Recall initiated | 2023-10-18 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | 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 |
| Quantity | 110 units |
| Reason classes | software |
| Model numbers | 100-240V, 1440W, 50/60HZ, MON-000005-01 |
Product
Monarch Platform REF MON-000005-01, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0448-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.