Recall Or Safety Alert for da Vinci instruments

According to Austrian Federal Office for Safety in Health Care (BASG), this recall or safety alert involved a device in Austria that was produced by Intuitive Surgical 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
    Recall / Safety alert
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 recall data from the U.S. and Austria.
  • Extra notes in the data
  • Reason
    Intuitive surgical, manufacturer of the da vinci surgical robot, has submitted this opinion in the context of the above-mentioned case. from the point of view of the basg, the reprocessing of the surgical instruments does not pose an increased risk, which could be attributed to the surface condition or surface changes. the need to validate the entire treatment process (cleaning, disinfection, maintenance and inspection, sterilization and storage) remains unaffected.