FDA Device recall Z-0270-2014
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0270-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-19 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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 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. K110834: AW 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. K081985: AW 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.
Reason
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
Identifiers
| code_info | Mfg Lot or Serial # 00000270627GE3 00000334603GE8 00000323252GE7 00000315108GE1 00000291160GE0 00000218194GE9 00…Mfg Lot or Serial # 00000270627GE3 00000334603GE8 00000323252GE7 00000315108GE1 00000291160GE0 00000218194GE9 00000334300GE1 00000253041GE8 00000256043GE1 00000L3A331FA4 00000289595GE1 00000323665GE0 00000323664GE3 00000275711GE0 00000293133GE5 00000256042GE3 00000175340GE9 00000335983GE3 00000275712GE8 00000275709GE4 00000323672GE6 00000323671GE8 00000226324GE2 00000208598GE3 00000187433GE8 00000187429GE6 00000226323GE4 00000304907GE9 00000327610GE2 00000303033GE5 00000308064GE5 00000318457GE9 00000306536GE4 00000304924GE4 00000LA70CA012 00000187434GE6 00000321124GE0 00000321123GE2 00000222541GE5 00000284793GE7 00000298539GE8 00000171505GE1 00000304914GE5 00000304910GE3 00000303035GE0 00000303034GE3 00000229351GE2 00000315104GE0 00000327604GE5 00000337320GE6 00000280422GE7 00000L0372A1AE 00000275708GE6 00000270631GE5 00000260247GE2 00000224182GE6 00000207773GE3 00000334305GE0 00000334304GE3 00000334303GE5 00000332778GE0 000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0270-2014%22
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