FDA-Device2024-10-16Class II
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
AURIS HEALTH INC
Hazard
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.
Sold states
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.
Affected count
4
Manufactured in
150 Shoreline Dr, Redwood City, CA, United States
Products
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2025Don't want to check this manually?
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