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Recall for Carto® 3 System Interface Cable, Biosense Webster

2010.11.03

Product group Medical electronics / Electromedical devices
Reference 03749/10

Biosense Webster has issued a Field Safety Notice concerning a recall of all lots of the Interface Cable, catalogue number CR3410CT which is used to connect the Celsius® Ablation Catheter to the Carto® 3 electrophysiology (EP) navigation system. The cable possibly may cause a short circuit to the Carto® 3 analog ground and in the worst case scenario may generate a DC current through the patient which might induce ventricular fibrillation.

Recall for Carto® 3 System Interface Cable, Biosense Webster , Download_VeroeffentlichtAm_EN PDF, 118KB, File does not meet accessibility standards

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