GE Healthcare — Class II medical device recall Z-1137-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-24, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the
| Recall number | Z-1137-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-06-28 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, IL, IN, IT, JP, KR, MY, NL, NO, NZ, PA, PL, QA, RO, RU, SA, SE, SG, TH, TR, ZA |
| Quantity | 429 |
| UPC / GTIN / UDI-DI | 00000001010008, 00000001010015, 00000001010022, 00000001010039, 00000001010046 |
| Serial numbers | 000001010001GS, 000001010002GS, 000001010003GS, 000001010004GS, 000001010005GS, 000001010007GS, 000001010008GS, 000001010009GS, 000001010012GS, 000001010013GS, 000001010015GS, 000001010016GS, 000001010017GS, 000001010018GS, 000001010020GS, 000001010022GS, 000001010023GS, 000001010024GS, 000001010026GS, 000001010027GS, 000001010028GS, 000001010030GS, 000001010031GS, 000001010033GS, 000001010035GS and 404 more |
Product
GE Healthcare, AW Server. Product Usage: . 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 with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
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-1137-2013. 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.