GE Revolution CT Scanners Recalled for Potential Head Scan Artifacts
GE Medical Systems is recalling 125 Revolution CT scanners worldwide due to potential image artifacts in head scans that may mimic pathology. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical imaging) where injury has not yet been reported, fitting the 'High' severity criteria for potential diagnostic errors without confirmed harm.
Plain-English summary
GE Medical Systems, LLC is recalling 125 units of the GE Healthcare Revolution CT scanner. These systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall covers 37 units in the United States and 88 units in other countries, including Australia, Canada, China, and the United Kingdom.
The recall is due to a potential issue with routine head scans where artifacts may appear in the images. These artifacts can emulate pathology between the brain tissue and bone, creating a potential hazardous situation for diagnostic interpretation. GE Healthcare became aware of this issue recently.
No injuries have been reported to date related to this issue. The affected units are identified by specific serial numbers and system IDs listed in the official recall documentation. Healthcare facilities should contact GE Medical Systems for instructions on how to address the issue.
The recalled product
- Product
- GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Manufacturer
- GE Medical Systems, LLC
Distribution
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