PlainRecalls
FDA Devices Moderate Class II Ongoing

Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

Reported: December 13, 2023 Initiated: October 18, 2023 #Z-0450-2024

Product Description

Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

Reason for Recall

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Details

Recalling Firm
AURIS HEALTH INC
Units Affected
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.
Location
Redwood City, CA

Frequently Asked Questions

What product was recalled?
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w. Recalled by AURIS HEALTH INC. Units affected: 110 units In total.
Why was this product recalled?
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0450-2024.