Recall archive / FDA device enforcement
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w — FDA record Z-0449-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Reason
- Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Classification
- Class II
- Recalling firm
- AURIS HEALTH INC
- Quantity
- 110 units In total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0449-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software version 2.2.4 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Dec 13, 2023
- Recall initiation date
- Oct 18, 2023
- Center classification date
- Dec 1, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.