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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1251-2017

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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