Device product
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Z-0449-2024
Product summary
- Firm
- AURIS HEALTH INC
- Event
- Event 93320
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 110 units In total
- Official record key
device-enforcement:Z-0449-2024
Official wording
Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Code information: Software version 2.2.4
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software issues may result in