Z-0052-2025 Class II Ongoing
FDA device recall Z-0052-2025 was initiated by AURIS HEALTH INC on Aug 2, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 16, 2024
- Initiation Date
- Aug 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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.
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.
Code Information
Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000007/+B634MON0000070/120059, 120133, 210002; MON-000007-RFB/10810068810889/210001.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0052-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026