FDA Device recall Z-0560-2013

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 whe…

FDA Device
Class II
terminated
Published 2012-12-26

On 2012-12-26 the FDA classified a Class II recall of 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 whe… by Ge Healthcare, citing 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 wit….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0560-2013
Classification	Class II
Status	terminated
Initiated	2012-05-29
Published	2012-12-26
Last updated	2026-09-13 11:53 UTC
Company	Ge Healthcare
Distribution	AL, CA, CO, FL, GA, IA, IL, IN, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI

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

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

Identifiers

code_info	"FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH" Mfg Lot or Serial # 00000L0219A4C4 00000L02167897 0000… "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 00000

code_info

"FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH" Mfg Lot or Serial # 00000L0219A4C4 00000L02167897 0000…

"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 00000

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0560-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.