Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Reported: October 16, 2024 Initiated: August 2, 2024 #Z-0052-2025
Product Description
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
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.
Details
- Recalling Firm
- AURIS HEALTH INC
- Units Affected
- 4
- Distribution
- 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.
- Location
- Redwood City, CA
Frequently Asked Questions
What product was recalled? ▼
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB. Recalled by AURIS HEALTH INC. Units affected: 4.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0052-2025.
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