GE Advantage CT/PET Fusion for Advantage Windows Workstation with… — Class II medical device recall Z-1960-2012
Terminated recall by GE Healthcare, LLC, reported 2012-07-18, distributed nationwide. GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET imag
| Recall number | Z-1960-2012 |
|---|---|
| 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 | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2012-12-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CA, CL, CN, DE, EG, ES, FR, GB, IE, IN, IT, JP, KE, SA, SG, TN, TR, TW |
| Quantity | 70 |
| UPC / GTIN / UDI-DI | 00082445010004 |
Product
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).
Reason for recall
GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
Machine access
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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.