Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

FDA device recall Z-0052-2025 · posted 2024-10-10 · Open, Classified

Recall details

Recalling firm

AURIS HEALTH INC

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.

Action taken

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 any personnel in your facility who need to be informed. If any affected products have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 5) Complete are return the acknowledgement form via email to MonarchSupport@its.jnj.com 6) If you feel that your power cord is damaged or defective or have questions , please contact MONARCH Support at 1-800-434-0032 or MonarchSupport@its.jnj.com to obtain a replacement that has been screened for this defect.

Root cause

Device Design

Status

Open, Classified

Product code

FGB

Quantity 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

Date initiated

2024-08-02

Date posted

2024-10-10

Location

Redwood City, CA

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