GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues
GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.
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, and the hazard involves a risk-of-harm product (medical imaging software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling the GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software, versions 4.0, 4.1, and 4.2. The recall involves 70 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated due to a potential safety issue where fused CT and PET images may be incorrectly aligned. The Volume Viewer application allows simultaneous viewing of registered PET and CT studies in fused mode, but the images may not align properly.
Healthcare facilities should contact GE Healthcare for further instructions on how to address this software defect.
The recalled product
- Product
- GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
- Affected units
- 70
Distribution
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