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Terminated

CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.

FDA Recall Z-1045-2014 · Posted 2014-02-20

Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2014-02-12
Date Terminated2014-05-23
Product Quantity8 units total (5 units in US)

Reason for Recall

Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.

Firm Action

Biosense Webster sent an Urgent Field Safety Notice dated February 12, 2014, to all affected customers to inform them that Biosense Webster has become aware of an issue with a particular configuration of the CartoUnivu Module withn the Carto 3 System (v3.2.2 and v3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact their Biosense Webster sales representative or cal (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions about the acknowledgement form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120550CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)Biosense Webster, Inc. · 2012-05-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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