GE Healthcare, LLC Recall 88208
Description: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
GE Healthcare, LLC Recall 88208 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2023-2021 |
| Event ID | 88208 |
| Event Description | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. |
| Product Type | Devices |
| Distribution | US |
| Recall Reason | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. |
| Device Classification | 20210714 |
| Device Code Info | Revolution CT |
| Center Classification Date | 20210708 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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