GE Healthcare Recalls CT Scanners Due to Potential Image Artifacts
GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.
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 device) where the hazard is diagnostic error (misdiagnosis) and no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 64 units of the Revolution Apex and Revolution CT with Apex Edition (Model 5995000-5) Computed Tomography systems. The recall is due to a potential for smudge artifacts in some images caused by incorrect settings. These artifacts could be mistaken for pathology, potentially affecting diagnostic accuracy.
The affected devices were distributed worldwide, including in the United States and various international markets. The systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.
Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. No specific instructions for individual patients are provided in the source text, but patients should consult their healthcare providers regarding any recent CT scans performed on these devices.
The recalled product
- Product
- Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 5995000-5
Distribution
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