Safety Alert for CERAGEM-E Massage Bed

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

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
    2011-12-13
  • 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
    Field safety notice: amendments to instructions for use of ceragem-e massage bed the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice regarding ceragem’s “ceragem-e massage bed”. medical device manufacturer, ceragem, informed users that additional instructions have been made to the user manual. 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 product, please contact your supplier for necessary actions.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Amendments to instructions for use of CERAGEM-E Massage Bed
  • Manufacturer

Manufacturer