Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Monarch Platform REF MON-000005-01 Recalled by AURIS HEALTH INC Due to Their is the potential that software issues may...

Date: October 18, 2023
Company: AURIS HEALTH INC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AURIS HEALTH INC directly.

Affected Products

Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

Quantity: 110 units In total

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 34 states: AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, WV, WI, DC

Affected (34 states)Not affected

About AURIS HEALTH INC

AURIS HEALTH INC has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report