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Safety risk concerning dental unit PROPHY RELAX

Reference No.: 1883/06

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 DevicesMedical Devices DivisionKurt-Georg-Kiesinger-Allee 3
53175 Bonn
Facsimile: (0228) 207-5300
E-Mail: medizinprodukte@bfarm.de
Telephone: 0228-99-307-5382 (Non-active medical devices - Dr. Heinz)
Telephone: 0228-99-307-5360 (In vitro diagnostic medical devices - Prof. Dr. Siekmeier)
Telephone: 0228-99-307-5384 (Active medical devices - Dr. Stößlein)