GE Healthcare Recalls MRI Systems Due to Image Flip Issue
GE Healthcare is recalling specific MRI systems because reformatted images may display a left-to-right flip, potentially affecting diagnostic accuracy.
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, and the hazard involves potential misinterpretation of diagnostic images without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling specific MRI systems, including the Optima MR360/Brivo MR355 (HDsv), 0.35T Signa Ovation HD, and 0.2T Signa Profile HD, due to a Reformat Image Flip Issue. The recall affects 864 units, with 57 located in the United States and 802 outside the US.
The issue involves axial and coronal reformatted images from sagittal 3D series of over 126 slices, which may display a left-to-right image flip. Additionally, acquired sagittal images may have reversed left-right location annotations. This defect could lead to misinterpretation of diagnostic images.
The recall is distributed worldwide, including the United States (nationwide, including DC and Puerto Rico, excluding Rhode Island). Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the issue.
The recalled product
- Product
- GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Systems
- Hazard
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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