URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Publicado el 8 de marzo de 2017 · Inicio del retiro: 12 de diciembre de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Olympus Corporation of the Americas
- Distribuidor
- Distributed Nationwide
- Lote
- All serial numbers are affected.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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