Recall Z-0052-2025 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
AURIS HEALTH INC
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
| Date | Oct 10, 2024 (initiated Aug 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 8/2/24, field safety notices were emailed to customers informing them of the following: 1) If the flow of electricity stops, the system may switch to battery backup power to allow for safe system shutdown. 2) Prior to use, carefully inspect the cords for any signs of excessive wear or damage while not plugged into an electrical outlet. 3) Firm is sourcing new replacement power cords to increase their robustness. New power cords will be provided as replacements once they are available. A member of MONARCH support will contact you to coordinate the replacement. 4) Forward this notice to a |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213334 | Monarch Platform, Urology Auris Health, Inc., Apr 29, 2022 |