Events

Safety Alert for Motus Laser Therapy Device (Model EA-Cure)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Not specified.

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
    1
  • Date
    2018-02-15
  • 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
    The medical device is not marked with the number of the notified body (does not comply with points 39 and 40 of the regulation); no information on the manufacturer and its address is provided on the label of the medical device or in the instructions for use (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); the name of the model (hdcure max) on the label embedded in the medical device packaging does not match the model name on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.2 of the regulation).
  • Action
    Cancel and remove from the market of the Republic of Lithuania

Device

Motus Laser Therapy Device (Model EA-Cure)

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH