MHRA issues warning on Tianjie Dental ‘Falcon’

MHRA issues warning on Tianjie Dental ‘Falcon’
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.

The Medical Device Alert can be found at:

http://www.mhra.gov.uk/home/groups/dtsbs/documents/medicaldevicealert/con173763.pdf

The Genereal Dental Council (GDC) has highlighted the warning from the Medicines and Healthcare Products Regulatory Agency (MHRA) about this type of scanner. The GDC is reminding all registrants that its ‘Standards for dental professionals’ says registrants should put patients’ interests first and act to protect them. In addition they must find out about laws and regulations which affect their work, premises, equipment and business, and follow them.
The GDC adds that more information about this issue can be found here:

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON173752?tabName=Problem

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