Karl Storz Photodynamic Diagnosis (PDD) DLight C System,

  • Model / Serial
    The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System.   Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and  TX2035.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
  • Product Description
    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, || Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. || Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 2151 East Grand Avenue, El Segundo CA 90245
  • Manufacturer Parent Company (2017)
  • Source
    USFDA