Company: AURIS HEALTH INC
Date of Enforcement Report: 12/01/2023
Class II
PRODUCT
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Recall Number:
Z-0448-2024
REASON:
There is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
RECALLING FIRM/MANUFACTURER:
AURIS HEALTH INC.
VOLUME OF PRODUCT IN COMMERCE:
110 units In total
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.
