Events

Safety Alert for Polymerization lamps Xlite - II

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Osakadent Group Ltd., China.

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
  • Event Number
    15
  • Date
    2015-05-13
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Extra notes in the data
  • Reason
    There are no data on the manufacturer on the medical devices themselves. the serial number is indicated only on the sales packaging of medical devices. the model shown on the medical device packaging and the medical device itself does not coincide with the medical device model specified on the instructions for use. the instructions for use do not contain any information on the manufacturer.
  • Action
    Disallowed to market

Device

Polymerization lamps Xlite - II

Manufacturer

Osakadent Group Ltd., China
  • Manufacturers representative
    UAB „Eurilija“
  • Source
    MH