Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 Wo

U.S. FDA — Device Enforcement · United States · 2012-05-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0560-2013
Date of alert: 2012-05-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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