Safety Alert for Puma, Beatle, Alex and Ibis XP power wheelchairs

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Handicare Ltd.

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
    2011-11-15
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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
    Mhra field safety notice: handicare puma, beatle, alex and ibis xp power wheelchairs the medicines and healthcare products regulatory agency (mhra) has issued a safety notice concerning the compact lights on puma, beatle, alex and ibis xp power wheelchairs manufactured by handicare ltd. handicare explained that the lights might cause overheating and, as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare is now replacing the lights in the compact lights unit by new led lights. this precautionary action will affect puma, beatle, alex and ibis xp power wheelchairs equipped with compact light units sold from november 2003 up to and including september 2011. according to the manufacturer, the majority of the affected products were distributed to the netherlands and also to canada and some european countries. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs
  • Manufacturer

Manufacturer

  • Source
    DH