AW VolumeShare 4 — Class II medical device recall Z-0270-2014
Terminated recall by GE Healthcare, LLC, reported 2013-11-20, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI vi
| Recall number | Z-0270-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-09-19 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CN, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HN, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LT, LU, LV, MX, NL, NO, NZ, PL, PT, RU, SA, SE, SG, TH, TR, TW, UA, ZA |
| Serial numbers | 000000G9337001, 000000G9337002, 000000G9337003, 000000G9337004, 000000G9337005, 000000G9337006, 000000G9337007, 000000G9337008, 000000G9337009, 000000G9337010, 000000G9337012, 000000G9337013, 000000G9337014, 000000G9337015, 000000G9337016, 000000G9337017, 000000G9337018, 000000G9337019, 000000G9337020, 000000L9343001, 000000L9343002, 000000L9343003, 000000L9343004, 000000L9343005, 000000L9343006 and 475 more |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0270-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.