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Recall Observatory FDA recall evidence

Device product

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

Z-0449-2024

October 18, 2023

Class II

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

    reason.device_software_design · v1.0.0

    software issues may result in