[Recalled] 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 d
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 fun |
|---|---|
| Brand / manufacturer | GE Healthcare, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1960-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 May 2012 |
| EAN / barcode | 0847490042 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from GE Healthcare, LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.