FDAFDA · Alimentos y medicamentos·N.º oficial Z-2072-2016
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. 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 FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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