BEUDAMED
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    GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2010

    GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2010

    BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code IWY·June 5, 2007

    Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601

    FDA Recall
    Terminated ·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004

    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

    FDA Recall
    Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·July 3, 2015

    CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·February 9, 2012

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·February 15, 2011

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code MTD·April 14, 2016

    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code MTD·April 14, 2016

    SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OBJ·September 10, 2015

    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·September 10, 2015