FDAFDA · Alimentos y medicamentos·N.º oficial Z-1911-2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Publicado el 11 de junio de 2025 · Inicio del retiro: 5 de mayo de 2025
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
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Olympus Corporation of the Americas
- Distribuidor
- Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Guadeloupe, Guatemala, Honduras, Hong Kong, Iceland, India, Iraq, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Palestinian Authority, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Republic of the Congo, R¿union, Russia, Saudi Arabia, Senegal, Seychelles, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam, Yemen.
- Lote
- UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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