Events

Field Safety Notices about VERSAJET II Water Surgery System Console

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Smith & Nephew Medical Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-02-07
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    This letter informs you of a voluntary security corrective action concerning a limited number of versajet◊ ii (sersajet) water surgery system brackets manufactured by smith & nephew inc. usa and smith & nephew medical, united kingdom. this precautionary measure requires the modification / replacement of the device to ensure that the work in the consoles in question complies with the european directive on the restriction of the use of certain dangerous substances. the devices in question do not pose a safety risk to patients.

Device

VERSAJET II Water Surgery System Console

Manufacturer

Smith & Nephew Medical Ltd