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Non CE-marked portable dental X-ray units

Reference No.: 4696/12

Testing by the Health Protection Agency has revealed that the non-CE-marked Tianjie Dental Falcon device from the manufacturer Zhengzhou Electronic Equipment Co. 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

Facsimile:       +49 (228) 207-5300
e-mail:            medizinprodukte@bfarm.de
Phone:     +49 (228) 207-5384 (active medical devices and medical technology)