Safety Notice for Refa8 and Refa-ext physiological amplifiers, TMS International B.V.
2011.05.04
Product group Medical electronics / Electromedical devices
Reference 01621/11
Twente Medical Systems International B.V. TMSi has issued a Field Safety Notice concerning a corrective action of Refa8 and Refa-ext physiological amplifiers. Due to a production error of the amplifier there is the risk in the case of an invasive measurement that a patient is exposed to voltage if at the same time an accessory is used which is possibly also defective.