BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice for Unilect™ ECG Electrodes, Unomedical

Product group Medical electronics / Electromedical devices
Reference 00972/10

Unomedical Ltd. has issued a Field Safety Notice concerning a corrective action on Unilect™ ECG wet gel Electrodes. While electrodes are already in use, due to a manufacturing irregularity the electrode gel may migrate from its normal position underneath the sponge to fill the position between the sensor and the snap. This event may result in a malfunction of the device. The affected electrodes are being recalled.

Safety Notice for Unilect™ ECG Electrodes, Unomedical , Download_VeroeffentlichtAm_EN PDF, 49KB, File does not meet accessibility standards

Use of cookies

Cookies help us to provide our services. By using our website you agree that we can use cookies. Read more about our Privacy Policy and visit the following link: Privacy Policy (only in German)

OK