The Mammendorfer Institut recalls the ECG Boy
2006.01.02
Product group Medical electronics / Electromedical devices
Reference 02357/05
The Mammendorfer Institut für Physik und Medizin GmbH informs about a recall of the ECG Boy (article-number EFMRZ033). The ECG Boy is an accessory to the magnetic resonance (MR) compatible patient monitor TeslaPlus and is designed to measure the skin resistance before connection of the ECG. The devices exhibit excessive Patient Auxiliary Currents of 70 μA to 80 μA, so that they do not meet the requirements of the standard IEC 60601-1.
Advisory Notice is only available in German language.
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