Source: https://www.whichmedicaldevice.com/news/article/98/mhra-issue-field-safety-notice-for-biosense-webster-carto-3-system
Timestamp: 2018-07-16 14:43:29
Document Index: 148351398

Matched Legal Cases: ['ARTO 3', 'ARTO 3', 'ARTO 3', 'ARTO 3', 'ART 3', 'ARTO 3']

News | MHRA issue field safety notice for Biosense Webster CARTO 3 System | Which Medical Device
Home > News > MHRA issue field safety notice for Biosense Webster CARTO 3 System
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.