FDA Device recall Z-0448-2024
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w by Auris Health, citing their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0448-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-18 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Auris Health |
| 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 |
Product
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Reason
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Identifiers
| code_info | Software Version 2.2.4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Auris Health
- MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Device · Class II · 2026-02-25 · Auris Health - MONARCH Bronchoscope
FDA Device · Class II · 2025-11-26 · Auris Health - Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Device · Class II · 2024-10-16 · Auris Health - Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB
FDA Device · Class II · 2024-10-16 · Auris Health - Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0448-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.