FDAFDA · Alimentos y medicamentos·N.º oficial Z-2280-2016
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Publicado el 3 de agosto 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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Pentax Medical Company
- Distribuidor
- US Nationwide Distribution
- Lote
- Model #'s FS-34V, ES-3831, ES-3870K and ES-3840
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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