GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues
GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.
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 is classified as FDA Class II. The hazard involves image quality issues (CT number variance) and software defects in a medical device, which poses a risk of harm or misdiagnosis, but the source does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 244 GE LightSpeed CT750 HD Computed Tomography X-ray systems. The recall involves two specific events. The first event involves a report of CT number variance in the timeline at the posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, they result in subtle differences in the CT numbers.
The second event involves a software defect, though the specific nature of the defect is not fully detailed in the provided source text. The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries such as Australia, Belgium, Brazil, Canada, China, and the United Kingdom.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address these software and image quality issues.
The recalled product
- Product
- GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray 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…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 244
Distribution
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