GE Healthcare Volume Viewer Plus 5 — Class II medical device recall Z-0901-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-13, distributed in AR, CA, CO, FL, GA, IA, IL, IN…. Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues invo
| Recall number | Z-0901-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-05-25 |
| Classified | 2013-03-01 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2014-01-28 |
| Distributed | AR, CA, CO, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, PA, PR, SC, SD, TN, TX, VA |
| Countries outside the US | AR, AT, AU, CA, CH, CL, CN, CZ, DE, DZ, EG, ES, FI, FR, HK, IE, IN, IT, JP, KE, KR, MT, MX, NG, PH, PT, SA, TN, TR, TW, VE |
| Quantity | 363 |
| UPC / GTIN / UDI-DI | 00000000010009, 00000000010016, 00000000010030, 00000000010047, 00000000010054, 00000000010061, 00000000010078, 00000000010092 |
Product
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
Reason for recall
Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
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-0901-2013. 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.