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U.S. Department of Health and Human Services

Class 2 Device Recall Advantage Workstation

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 Class 2 Device Recall Advantage Workstation see related information
Date Posted December 19, 2012
Recall Status1 Terminated on January 17, 2013
Recall Number Z-0560-2013
Recall Event ID 61593
Product Classification System, image processing, radiological - Product Code LLZ
Product 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 system: Select 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 use: K993792: 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. K031261: Card 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. K041267: CardIQ 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. K061370: CardIQ 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
Code Information F
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Software design
Action GE Healthcare sent two Urgent Medical Device Correction letters dated May 23, 2012, to all affected customers. Each letter addressed a separate issue. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers were instructed to use the following precautions until corrected software was installed: 1. Please avoid the use of leading or trailing spaces in Vessel Names 2. Be sure to press "Show Tracking" after depositing new bifurcation points 3. When eating a multi-point vessel tracking, remove and replace the entire branch, not only the final end-point. 4. When analyzing multi-phase cardiac images, do not delete vessel branches from a phase other than the one in which it was created. Customers were instructed that the new application version that addresses this issue will soon be installed on all systems. Customers with questions or concerns were instructed to call the following: United States 1-800-437-1171. Japan 0120-055-919 For other countries they were instructed to contact their GE Healthcare Service Representative. For questions regarding this recalla call 262-513-4122
Quantity in Commerce 548 (118 USA; 430 OUS)
Distribution Worldwide Distribution - USA including AL, CA, CO, FL, GA, IL, IN, IA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX , UT, VA, WI and Internationally to the following countries: VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SOUTH AFRICA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, ROMANIA, REUNION, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, NORWAY, NIGERIA, NEW CALEDONIA, NEPAL, MEXICO, MALAYSIA, KOREA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA ALGERIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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