Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5…
Medical device recall Z-0560-2013. Published in FDA’s Enforcement Report on Dec 26, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 26, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 31 states named in where it went
- 548 (118 USA; 430 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
548 (118 USA; 430 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
“FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH” Mfg Lot or Serial # 00000L0219A4C4 00000L02167897 00000L022D0776 00000L0240826C 00000L022924AF 00000L02408728 00000L020E7DEF 00000L02167D50 00000L0219CA0A 00000L025A16BA…
Every code shown here, 1,999 characters
“FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH” Mfg Lot or Serial # 00000L0219A4C4 00000L02167897 00000L022D0776 00000L0240826C 00000L022924AF 00000L02408728 00000L020E7DEF 00000L02167D50 00000L0219CA0A 00000L025A16BA 00000L02408829 00000L02A1CED2 00000L02127C08 00000L021DFF09 00000L021DFE8C 00000L022925D3 00000L0246B1BB 00000L020E81FF 00000L027461C8 00000L02A13D92 00000L020E0003 00000L021653EE 00000L0213E474 00000L0213E7BA 00000L020E0A27 00000LEE1A74B4 00000L022EE8A6 00000L0235EED0 00000L022922EE 00000L026FFFE3 00000L02127CD6 00000L020E7E4E 00000L0215A47D 00000L6100B6EA 00000L0271A0AE 00000L020E0B95 00000L0276200E 00000L02762053 00000L027623AC 00000L0219C966 00000L021562BA 00000L0246B24D 00000L02408351 00000L02167DC8 00000L020E0AEA 00000L02408638 00000L0235EB60 00000L022D06CA 00000L022D06E2 00000L0246B17D 00000L02127B57 00000L022EE879 00000L027003FD 00000L0235EBFD 00000L02156750 00000L02A79998 00000L02165328 00000L0216769F 00000L02167E0C 00000L02167EC0 00000L02700194 00000L027004A8 00000L027004E6 00000L027452E6 00000L02408796 00000L022EE8B6 00000L02408432 00000L022923B7 00000L3ABB095C 00000L02A05D3B 00000L024085E7 00000L02127D54 00000L0235EB68 00000L025ADA7A 00000L024086A0 00000L02408505 00000L020E07D8 00000L0219C95D 00000L02292338 00000L0240826B 00000L02127C79 00000L022EE7E9 00000L0247FE35 00000LEE1B09F2 00000L02141CDF 00000L029FDC14 00000L0235EC8A 00000L0264CECC 00000L020D73A0 00000L0229247D 00000L022926B7 00000L0235EC49 00000L02A8C496 00000L02167E0F 00000LEE16BE1E 00000L0219A361 00000L027006B3 00000L0246B17C 00000L0246DE23 00000L0247E3DF 00000L021DFE83 00000L022D0782 00000L022EE7E8 00000L022EE7FF 00000L02A8C644 00000L0270036E 00000L020CFA70 00000L02019944 00000L021279D4 00000L0240883C 00000L020E028F 00000L02A13F87 00000L0235EB43 00000L020B0B01 00000L0271A514 00000L0213E6C6 00000L02A79744 00000L02A76C57 00000L02547251 00000L026EAACE 00000L027463B5 00000L0264CEEA 00000L020D64E1 00000L020E07CB 00000L0238B0B2 00000L024083B9 00000L025B57DD 00000L02577C13…
FDA’s list runs to 8,298 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
31 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 29, 2012.
- FDA classified it on Dec 19, 2012.
- FDA’s Enforcement Report published it on Dec 26, 2012.
- FDA terminated it on Jan 17, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,298 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.