PlainRecordsFDA · Medical device recall
The system is intended to produce cross-sectional images of the body… and 2 more products
- Date
- July 14, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- GE Healthcare, LLC
- 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.
- Distribution pattern
- US
3 products in this recall
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Product
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or 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. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
- Codes and lots
- Revolution CT
- Recall started
- June 30, 2021
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Process design
- Recall number
- Z-2021-2021
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Product
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or 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. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
- Codes and lots
- Revolution CT
- Recall started
- June 30, 2021
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Process design
- Recall number
- Z-2022-2021
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Product
- 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.
- Codes and lots
- Revolution CT
- Recall started
- June 30, 2021
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Process design
- Recall number
- Z-2023-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2021-2021, Z-2022-2021, Z-2023-2021. The agency record governs; check it and the company before acting.