Safety Alert for SEDASYS Computer-Assisted Personalized Sedation System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ethicon Endo-Surgery Inc.

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: ethicon sedasys computer-assisted personalized sedation system the united states food and drug administration (fda) has issued a medical device safety alert concerning sedasys computer-assisted personalized sedation system [product code: sedpru01], manufactured by ethicon endo-surgery inc. the manufacturer has found that disinfecting methods not specified in the instructions for use (ifu) have led to the degradation of the plastic material of the sedasys system control unit. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2374-2015&w=09022015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions posted on 7 september 2015.