FDAFDA · Food and drugs·Recall number Z-0051-2025
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Published October 16, 2024 · Recall initiated: August 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AURIS HEALTH INC
- Distributor
- 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.
- Lot
- 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-000005-01/+B634MON000005010/110024, 13, 110014, 110016, 110040, 110038, 110027, 110035, 110022, 110034, 1806P2, 120170, 110045, 110039, 110049, 110047, 110052, 110030, 110032, 110021, 110043, 110050, 110029, 110033, 110046, 110048, 110018, 110015, 110051, 1806P1, 110012, 14, 110041, 110036; MON-000005-01R/+B634MON00000501R0/110020, 110017, 110031, 110028, 120042, 110013. MON-000006/+B634MON0000060/120088, 120057, 120046, 120058, 120121, 120152, 120015, 120160, 120068, 120167, 120025, 120030, 120044, 120093, 120040, 120063, 120092, 120173, 120036, 120064, 120122, 120056, 120128, 120017, 120089, 120075, 120031, 120169, 120113, 120168, 120055, 120148, 120014, 120060, 120124, 120164, 120123, 120007, 120006, 120004, 120120, 120126, 120082, 120047, 120051, 120020, 120103, 120153, 120108, 120037, 120074, 120005, 120130, 120095, 120096, 120009, 120111, 120022, 120054, 120163, 120027, 120090, 120141, 120072, 120155, 120101, 120143, 120125, 120052, 120100, 120050, 120098, 120045, 120131, 120013, 120105, 120165, 120136, 120029, 120041, 120139, 120137, 120053, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 120145, 120127, 120011, 120070, 120076, 120134, 120117, 120077, 120149, 120102, 120002, 120010, 120003, 120023, 120146, 120043, 120071, 120107, 120065, 120116, 120150, 120066, 120166, 120033, 120079, 120008, 120132, 120086, 120032, 120073, 120016, 120080, 120078, 120012, 120084, 120083, 120038, 120067, 120021; MON-000006-RFB/+B634MON0000060/120081, 120026, 120091, 120106, 120104.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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