Testing by the Health Protection Agency has revealed that the non-CE-marked Tianjie Dental Falcon device from the manufacturer Zhengzhou Electronic Equipment Co.--Company lacks sufficient shielding, which could give rise to high patient and operator doses. MHRA recommends to stop using this and similar non CE-marked devices.

MDA/2012/046

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-5384 (active medical devices and medical technology)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de