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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.

Safety Notice concerning a corrective action of the electrophysiology (EP) system Carto 3, Biosense Webster , Download_VeroeffentlichtAm_EN PDF, 667KB, File does not meet accessibility standards

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