Philips MRI Systems Recalled for Incorrect Diffusion Tensor Imaging Data Exports
Philips is recalling 91 Evolution MRI systems because Enhanced MR DICOM exports contain incorrect diffusion directions, preventing correct tractography reconstruction.
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. The hazard involves incorrect data export affecting downstream software processing, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Philips North America is recalling 91 Evolution upgrade 1.5T and 3.0T MRI systems. The recall involves specific model numbers and software versions R11, R12, and R13. The systems were distributed worldwide, including in the United States and numerous international countries.
The recall is due to a software defect where exporting diffusion tensor imaging (DTI) scans using the Enhanced MR DICOM format results in incorrect data regarding diffusion directions. If this exported data is used with third-party software for tractography, such as mapping nerve fiber pathways in the brain, the software cannot correctly process the data for reconstruction.
Healthcare facilities and users of these specific MRI systems should contact Philips North America for further instructions on how to resolve the data export issue.
The recalled product
- Product
- Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Model number (REF): 782116 (1.5T)
- UDI-DI: 00884838099722
- Serial Numbers: 41042
- 41235
- 41287
- 41295
- 41367
- 41505
- 41568
- 70068
- 70093
- 70995
- 70996
- 84370
- 2. Model number (REF): 782148 (1.5T)
- UDI-DI: 00884838108714
- Serial Numbers: 41011
- 41031
- 41110
- 41244
Distribution
Distributed nationwide across the United States.
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