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Information on Scooter Sungift 500

Reference No.: 0139/06

In Norway, Scooter Sungift 500 has been withdrawn from the market in 2005. There has been an incident with ignition of the product, presumably caused by damage of electric cables as a result of vibrations when driving the scooter.

According to our information, the British manufacturer Sungift PLC does not exist any more and we do not know of any subsequent owner. We do not have detailed information on the presumed causation of the fire or on the presence of the product in the German market.

In case that some of the concerned devices may be used in Germany, BfArM recommends at least to have the scooters inspected and – depending on the situation of the cables – not to use it any more.

According to the German medical devices act, supervision of users and facilities is a matter of the Federal Competent Authorities.

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 99 307-5306 (active and in vitro diagnostic medical devices)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de

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