GE Healthcare Advantage Workstations — Class II medical device recall Z-2203-2012
Terminated recall by GE Healthcare, LLC, reported 2012-08-22, distributed nationwide. GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized
| Recall number | Z-2203-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-05-24 |
| Classified | 2012-08-13 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2012-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, ID, IE, IN, IT, JP, KE, KR, MT, MX, NG, NO, NZ, PH, PL, PT, RO, SE, SG, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,055 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00082421010110, 00082421030170, 00082421030248, 00082421040155, 00082421050055, 00082421070145, 00082421070183, 00082427150025, 00082427160048, 00082427310009 |
| Model numbers | 2378698-2 |
Product
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.
Reason for recall
GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
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-2203-2012. 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.