Reported Nov 20, 2013 · Terminated
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server.…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server
- K052995Advantage 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 imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images
- K110834AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images
- K081985AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications
- Lot codes and dates
- Mfg Lot or Serial #
1,458 of 1,458 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 1458 (336 US, 1122 OUS)
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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