The Federal Institute for Drugs and Medical Devices was informed about an incident involving the dental unit PROPHY RELAX manufactured by HAMAPRO [NL] bzw. ITTER ELECTRONIC [NL]. The patient chair suddenly subsided during the therapy because of a broken bearing in the spindle drive.
Currently neither information about the cause nor the number of units that are actually in use is available nor a responsible manufacturer is determinable. Therefore, in case the dental unit is still in use, we recommend a technical checkup focussed on that particular issue.

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

Telephone: +49 (0)228 99 307-5382 (non-active medical devices - Dr. Heinz)
Telephone: +49 (0)228 99 307-5360 (in vitro diagnostics - Prof. Dr. Siekmeier)
Telephone: +49 (0)228 99 307-5384 (active medical devices - Dr. Stößlein)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de