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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial No. 13201, 11125, 11519, 11320, 11115.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biosense Webster, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
Serial No. 13201, 11125, 11519, 11320, 11115.
Distribution:
Distributed in: CA, KY, NJ, MA, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1045-2014
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