Events

Safety Alert for portable dental x-ray units

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Zhengzhou Tianjie Electronic Equipment 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
    2012-07-17
  • Event Date Posted
    2012-07-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120717.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
    Medical device safety alert: portable dental x-ray units the medicines and healthcare products regulatory agency (mhra) of the united kingdom has issued a medical device alert concerning non ce-marked portable dental x-ray units including the tianjie dental falcon, manufactured by zhengzhou tianjie electronic equipment co. according to the mhra, testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation. in addition, the tianjie dental falcon portable x-ray unit is not ce-marked as a medical device and could be purchased on ebay. it is identical in appearance to a number of other non ce-marked devices that are available on the internet. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm posted on 17 july 2012.

Device

portable dental x-ray units

Manufacturer

Zhengzhou Tianjie Electronic Equipment Co
  • Source
    DH