Device Recall Gendex CB500 3D Dental Imaging System

  • Model / Serial
    Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
  • Product Description
    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • Manufacturer Parent Company (2017)
  • Source
    USFDA