Device Recall Pentax Inc

  • Model / Serial
    EB-1970UK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source
    USFDA