AURIS HEALTH INC: Device Recall

Recall Details

Recall Number

Z-0051-2025

Classification

Class II

Product Type

Device

Recalling Firm

AURIS HEALTH INC

Status

Ongoing

Date Initiated

08/02/2024

Location

Redwood City, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

176

Reason for Recall

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.

Product Description

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

Distribution Pattern

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.

Other Recalls by AURIS HEALTH INC

• Class II: Risk 10/18/2025
  Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
• Class II: Risk 08/02/2024
  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.

View all recalls by AURIS HEALTH INC →