GE Healthcare Recalls MRI Scanners Due to Non-Unique Series Identifiers
GE Healthcare is recalling specific MRI scanners because they may generate non-unique series identifiers in image headers, which can cause data association errors when exported to PACS systems.
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, which typically corresponds to a moderate severity where the defect could cause temporary or medically reversible health consequences, or the probability of serious adverse health consequences is remote. No injuries or deaths are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling specific GE MRI scanner models, including the 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, and Discovery MR750w, due to a potential safety issue. The affected units are equipped with HD23 Software and specific model numbers listed in the recall notice.
The recall is issued because these products can generate image headers with non-unique series identifiers. When these images are exported to certain PACS (Picture Archiving and Communication System) systems, the non-unique identifiers can result in the series being incorrectly associated with other data. This issue affects 1,246 units distributed worldwide, including 521 units in the United States and 725 units outside the US.
Healthcare facilities and users of these MRI scanners should contact GE Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
The recalled product
- Product
- GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Scanner
Distribution
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