Devices

Device Recall Lumenis VersaCut Tissue Morcellator

  • Model / Serial
    GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
  • Product Description
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
    Lumenis
  • 1 Event

Manufacturer

Lumenis
  • Manufacturer Address
    Lumenis, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA