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

Recall Z-0270-2014 — AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic ima

U.S. FDA — Device Enforcement · United States · 2013-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0270-2014
Date of alert: 2013-09-19
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 recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc

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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