GE Healthcare Recalls MRI Scanners Due to Potential Image Orientation Errors
GE Healthcare is recalling 82 MRI scanners because a missing spacer may cause images to be flipped left-right with incorrect orientation annotations.
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 incorrect image orientation, which is a diagnostic accuracy issue rather than a direct physical injury risk, and no injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare is recalling 82 whole-body magnetic resonance diagnostic imaging scanners, including various Signa Infinity, Signa MR/i, and Signa HD models. The recall affects 39 units in the United States and 43 units distributed internationally to countries including the United Arab Emirates, Argentina, Brazil, and Canada.
The recall is due to a potential defect where a gradient cable in the ACGD cabinet may be missing a spacer. This spacer is designed to prevent the gradient cable terminals from connecting in the wrong polarity on the X gradient amplifier. If the terminals connect incorrectly, it could cause the resulting images to be flipped left-right with incorrect orientation annotations.
The source text does not specify specific actions for consumers or patients, nor does it report any injuries or illnesses associated with this defect. The recall is limited to the specific serial numbers and system IDs listed in the official FDA record.
The recalled product
- Product
- GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Scanner
Distribution
Distributed nationwide across the United States.
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