GE Healthcare, LLC 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 e Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 e
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Revolution CT
Products Sold
Revolution CT
GE Healthcare, LLC is recalling The system is intended to produce cross-sectional images of the body by computer reconstruction of x due to 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 confi. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026