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