Biosense Webster Recalls CartoUnivu Module for Map Misalignment
Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (misalignment of diagnostic aids) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity rating.
Plain-English summary
Biosense Webster, Inc. is recalling the CartoUnivu Module (Catalog No. KT-5400-124) used with the Carto 3 System (Software versions 3.2.2 and 3.2.3). The recall involves 8 units total, with 5 units distributed in the United States and the remainder distributed internationally to Belgium, Austria, and Germany. Affected serial numbers are 13201, 11125, 11519, 11320, and 11115.
The recall was initiated because the module may cause a misalignment between the Carto 3 System map display and fluoroscopic captures when used with Siemens Axiom Artis VB Fluoroscopy systems in specific procedural configurations. This misalignment occurs if the table rotation is not returned to zero point. The source text notes that these fluoroscopic images are not for diagnostic purposes.
Healthcare facilities should contact Biosense Webster for further instructions regarding the recall. No specific consumer actions are detailed in the source text beyond the initiation of the recall by the manufacturer.
The recalled product
- 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 FLU
- Manufacturer
- Biosense Webster, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial No. 13201
- 11125
- 11519
- 11320
- 11115.
Distribution
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