Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Publicado el 16 de octubre de 2024 · Inicio del retiro: 2 de agosto de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- AURIS HEALTH INC
- Distribuidor
- 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.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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