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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2065-2016

Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Publicado el 6 de julio de 2016 · Inicio del retiro: 6 de abril 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

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Pentax Medical Company
Distribuidor
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Lote
Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States