AURIS HEALTH INC: Medical Device Recall in 2023 - (Recall #: Z-0450-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 18, 2023

Date Posted: December 13, 2023

Recall Number: Z-0450-2024

Event ID: 93320

Reason for Recall:

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

Status: Ongoing

Product Quantity: 110 units In total

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.

Voluntary or Mandated:

Voluntary: Firm initiated