GE Healthcare — Class II medical device recall Z-1148-2014
Terminated recall by GE Healthcare, LLC, reported 2014-03-12, distributed nationwide. When performing a secondary capture generated from GSI Viewer, the header information is correct on the images
| Recall number | Z-1148-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-03-25 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CN, DE, DK, FI, FR, GB, GR, HK, ID, IL, IN, IT, JP, KR, KW, LV, NZ, PL, SA, SE, SG, TW, ZA |
| Serial numbers | 00000018579HP0, 000000G9337001, 000000G9337002, 000000G9337003, 000000G9337004, 000000G9337005, 000000G9337006, 000000G9337008, 000000G9337009, 000000G9337010, 000000G9337012, 000000G9337013, 000000G9337014, 000000G9337015, 000000G9337017, 000000G9337018, 000000G9337019, 000000G9337020, 000000L9343001, 000000L9343002, 000000L9343003, 000000L9343004, 000000L9343005, 000000L9343006, 000000L9343007 and 258 more |
Product
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
Reason for recall
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.
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-1148-2014. 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.