AURIS HEALTH INC recalls Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

Recall date

August 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0052-2025

FDA classification

Class II

Brand / firm

AURIS HEALTH INC

Sold / distributed

Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.

Why it was recalled

Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB