01
Dec
2023

FDA Recall: Software Issue Resulting in Flipped Images

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0

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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