Safety Notice concerning a corrective action of the electrophysiology (EP) system Carto 3, Biosense Webster
2012.02.27
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 00850/12
Biosense Webster has issued a Field Safety Notice concerning a corrective action of the electrophysiology (EP) system Carto 3. A newly introduced Patient Interface Unit (PIU) Backplane Card is more sensitive to radio frequency interference. This issue can manifest itself as a jumping or disappearing catheter icon and/or error messages during ablation. The PIU Backplane Card has to be replaced.