Reported Dec 26, 2012 · Terminated
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or
- more of these applications is installed" VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or
- both of these applications is installed" CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE
- OF FOLLOWING APPLICATIONS IS INSTALLED¿ VesselIQ Xpress or AVA Xpress ¿ CardIQ Xpress Pro or Plus ¿ CardEP ¿ CardIQ Fusion PET or SPECT provided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1. To verify
- the version installed on your systemSelect the Admin menu from the Patient list page. Then select Display Configuration . You will find the version of your system in Installed Application(s) . This version will appear as vxtl_7.x or vxtl_8.x
- Intended useK993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization
- K031261Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy
- K041267CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation, scanner operator console and PACS system
- K061370CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in severa
- Lot codes and dates
- "FMI# &
- DescriptionFMI 25409 VESSEL LABELLING MISMATCH" Mfg Lot or Serial #
548 of 548 codes
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
- Amount recalled
- 548 (118 USA; 430 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety. 2) A refresh problem of the stenosis / aneurysm measurement tools associated with the cardio-vascular applications of
This product could cause temporary or reversible health problems — stop using it.
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