Device Recall Pentax Rigid Laryngostroboscopes

  • Model / Serial
    Model #'s 9106 and 9108
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
  • 1 Event


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