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AURIS HEALTH INC recalls Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Recalled December 13, 2023 · FDA recall Z-0449-2024 · AURIS HEALTH
Hazard
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. · FDA Class II
Units
110 units In total
Sold at
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.
Description
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Product
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Manufacturer(s)
AURIS HEALTH INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →