Z-1045-2014Class II

CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE...

Name: Z-1045-2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE...
Creator: Biosense Webster, Inc.
Published: 2014-02-12
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2014-02-12 / Terminated

FDA source

Biosense Webster, Inc. began a recall of 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... on 2014-02-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1045-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-12
Posted: 2014-02-20
Terminated: 2014-05-23
Recalling firm: Biosense Webster Inc
Product: 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.
Product code: DQK Computer, Diagnostic, Programmable
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.
FDA root cause: Other
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.
Quantity in commerce: 8 units total (5 units in US)
Distribution: Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
Product codes and lots: Serial No. 13201, 11125, 11519, 11320, 11115.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1045-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code DQK

K120550Class IICarto(r) Ep Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. / cleared 2012-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)