The FDA Enforcement Report for the week of December 26, 2012 lists the ongoing GE Healthcare LLC recall of the Advantage workstation.
The recall involves various versions, such as the volume share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version 7.0 to version 7.5 and version 8.1). Additionally, these face a recall only when certain applications are installed, such as the VesselIQ Xpress or AVA Xpress, and more.
The recall notice provides instructions on how to verify the version installed on your system, as well as full details on versions and applications.
GE Healthcare issued the recall when it became aware of two issues with the Advantage workstation: A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardiovascular applications of the Advantage workstation that may impact patient safety, and a refresh problem of the stenosis/aneurysm measurement tools associated with the cardiovascular applications of the Advantage workstation that may impact patient safety.
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