BEUDAMED
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    Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·November 17, 2015

    Merge Cardio with software version 10.1 LA.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 26, 2015

    RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·December 17, 2015

    eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·August 28, 2014

    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 30, 2016

    Prestilix

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·November 21, 2016

    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 8, 2015

    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·January 30, 2016

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·October 15, 2015

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code LLZ·December 22, 2016

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code LLZ·June 1, 2018

    Syngo.via. Medical Device Software. Picture archiving and communications system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·January 8, 2018

    InstaTrak 3500 Plus Navigation and Visualization System

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004

    syngo Imaging, picture archiving and communications system. Model number 7502029

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·September 5, 2006

    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·December 12, 2008

    GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·September 25, 2009

    Syngo Imaging XS model number 10496279 The intended use: image processing radiological

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·February 16, 2010

    Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code LLZ·October 8, 2004

    IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·March 21, 2011

    ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·August 18, 2011