Z-0052-2025Class II

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

Name: Z-0052-2025 Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Creator: Auris Health Inc
Published: 2024-08-02
License: https://open.fda.gov/license/

Auris Health, Inc / initiated 2024-08-02 / Open, Classified / root cause: design

FDA source

AURIS HEALTH INC began a recall of Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB on 2024-08-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0052-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-02
Posted: 2024-10-10
Recalling firm: Auris Health, Inc
Product: Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Product code: FGB Ureteroscope And Accessories, Flexible/Rigid
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.
Root cause tag: design
FDA 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 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 [email protected] 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 [email protected] to obtain a replacement that has been screened for this defect.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0052-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-10
Z-0052-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-10

Product code FGB

K213334Class IIMonarch Platform, UrologyAuris Health, Inc. / cleared 2022-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)