Agency classClass IIOur severity:High FDA (Devices)·Z-0560-2013·Announced 2012-12-26

GE Healthcare Recalls Advantage Workstation Software Due to Vessel Label Mismatch

GE Healthcare is recalling specific Advantage Workstation software versions due to a potential vessel label mismatch and a measurement tool refresh issue that may impact patient safety.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly states that the vessel label mismatch 'may impact patient safety,' which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare, LLC is recalling specific versions of the Advantage Workstation software, including Volume Share 2 (version AW4.4_04) and Volume Viewer 3 and 3.1 (versions 7.0 to 7.5 and 8.1). The recall applies only when specific cardiovascular applications are installed, such as VesselIQ Xpress, AVA Xpress, CardIQ Xpress Pro or Plus, CardEP, or CardIQ Fusion PET or SPECT. Older versions, including Advantage Workstations Volume Share (v.AW4.3) and AW4.2, are also affected if paired with Volume Viewer 2 and specific applications.

The recall is being conducted due to two identified issues: a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardiovascular applications, and a refresh problem with the stenosis/aneurysm measurement tools. The source text notes that the vessel label mismatch may impact patient safety. The affected units were distributed worldwide, including in the United States and numerous international countries.

Healthcare facilities and users should verify their installed software versions by selecting the 'Admin' menu from the 'Patient list' page and then selecting 'Display Configuration' to view the 'Installed Application(s)'. Users should contact GE Healthcare for further instructions on how to address these software defects.

The recalled product

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Medical Imaging Software
Hazard: mis-labeling
software-defect

Distribution

Distributed in 31 states:

Same manufacturer · GE Healthcare, LLC

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