GE Optima CT Systems Recalled for Manual Film Composer Data Mismatch
GE Healthcare is recalling 272 Optima CT520 and CT540 systems because the Manual Film Composer feature may display or print images with incorrect patient names or mismatched image previews.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software workflow error that could lead to patient data mismatch, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 272 units of the GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. The recall involves 29 units in the United States and 243 units outside the US. These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall is due to an issue with the Manual Film Composer feature. When following a specific workflow, there is an opportunity to create a film image that contains one patient's images but displays another patient's name in the footer. Additionally, if a color image is selected for printing within the Manual Film Composer, a different patient's black and white image may appear in the preview screen.
The affected units are distributed worldwide, including in the United States (nationwide, specifically in AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA) and numerous countries such as Canada, China, France, Germany, and Japan. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue with the Manual Film Composer feature.
The recalled product
- Product
- GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer
- GE Healthcare, LLC
Distribution
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