Safety Alert for VersaCut Tissue Morcellator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Lumenis Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: lumenis versacut tissue morcellator the united states food and drug administration (fda) has issued a medical device safety alert concerning lumenis versacut tissue morcellator manufactured by lumenis limited. the affected model numbers are 0637-245-01 (starter kit) and 0636-470-01 (control box) which includes all products since initial product release in 1998. lumenis is recalling certain models of versacut morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product- tabs.Cfm?action=select&recall_number=z-0795-2013&w=02202013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 february 2013.