Recall Z-0052-2025— AURIS HEALTH INC
Class II · Ongoing
Class II FDA medical device recall by AURIS HEALTH INC, initiated 2024-08-02. It names one FDA 510(k) clearance: K213334. Product: Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB. 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..
- Recalling firm
- AURIS HEALTH INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-02
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.