Field Safety Notice concerning a corrective action of the digital neurophysiological systems from Neurosoft Ltd.
2008.11.25
Product group Medical electronics / Electromedical devices
Reference 04315/08
Neurosoft Ltd. issues a Field Safety Notice concerning a corrective action of the digital neurophysiological systems Neuro-MEP, Evidence 4004evo, Neuron-Spectrum-5, Neuron-Spectrum-5/S, Neuron-Spectrum-4/EPM and Neuron-Spectrum-4/EPM/S. In case the systems are used together with the electro stimulating electrode, there is the risk of electric shock hazard for patient and user. Before the inspection and/or the modification of the systems has been carried out, the stimulation electrodes may not be used any more.