GE Healthcare GSI Viewer Software Recall for Inaccurate Line Measurements
GE Healthcare is recalling GSI Viewer software because changing the region of interest or zooming may result in inaccurate line measurements.
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 2/5 (Moderate).
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 inaccurate measurements due to a software defect, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the Moderate severity criteria for non-critical labeling or functional errors.
Plain-English summary
GE Healthcare, LLC is recalling specific versions of the GSI Viewer software (models 5342114, 5342114-2, 5342114-3, 5342114-4, and 5401757) used with Computed Tomography X-Ray systems. The recall involves 283 units distributed worldwide, including 59 units in the United States and 224 units in other countries.
The recall is due to a software defect where the DICOM header does not update when a user changes the region of interest (ROI) or zooms in on an image. While the header information is correct on the initial images, this failure to update the header during secondary captures can cause line measurements to be inaccurate.
The affected software was distributed in 20 US states and numerous international locations, including Australia, Canada, China, and the United Kingdom. No specific consumer action is detailed in the source text beyond the identification of the affected units.
The recalled product
- Product
- GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5)…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
Distribution
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