Events

Safety Alert for Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Chien Ti Enterprise Co..

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
    2012-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120206.html
  • 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
    Field safety notice: leo 3-wheel scooter and leo scooter, model # leo-4b the food and drug administration (fda), united states, has issued a class ii recall on leo 3-wheel scooter and leo scooter, model # leo-4b, manufactured by chien ti enterprise co., ltd. according to the distributor, invacare corporations, the products are being recall because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the fda website: http://www.Fda.Gov/safety/recalls/enforcementreports/ ucm290086.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B
  • Manufacturer
    Chien Ti Enterprise Co.

Manufacturer

Chien Ti Enterprise Co.