Events

Recall of Device Recall Advantage Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61593
  • Event Risk Class
    Class 2
  • Event Number
    Z-0560-2013
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108512
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    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.
  • 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

Device

Device Recall Advantage Workstation
  • Model / Serial
    "FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH" Mfg Lot or Serial 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA