MHRA issue field safety notice for Biosense Webster CARTO 3 System

Published date : 22 February 2012
Article date : 22 February 2012

The MHRA has issued a field safety notice for the CARTO 3 System which may be susceptible to ablation radio frequency interference through certain interconnected cable configurations. The issue can manifest itself as a jumping or disappearing catheter icon or error messages during ablation.

Biosense Webster have issued a statement identifying the root cause of the issue as a newly introduced Patient Interface Unit (PIU) Backplane card, which is more sensitive to radio frequency interference. Biosense Webster is contacting institutions supplied with one of the affected CART 3 Systems with the new backplane card and will provide alternative equipment.

Read the full letter from Biosense Webster here.

Find out more about the CARTO 3 System here.

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