Philips Recalls Ingenia MRI Systems Due to Incorrect DTI Export Data
Philips is recalling 340 Ingenia MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate third-party processing.
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 that prevents accurate third-party processing, but no injuries, illnesses, or deaths are reported in the source text.
Plain-English summary
Philips North America is recalling 340 units of the Ingenia Elition S and Ingenia Elition X MRI systems. The affected units are distributed worldwide, including in the United States and numerous international markets. The recall involves specific model numbers and software versions R11, R12, and R13.
The recall is due to a software defect where exporting diffusion tensor imaging (DTI) scans using the Enhanced MR DICOM format results in incorrect diffusion direction data. 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 using these systems should contact Philips North America for instructions on how to resolve the issue. The defect affects the accuracy of specific data exports used in advanced imaging analysis.
The recalled product
- Product
- Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Affected units
- 340
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): 781357 (S)
- UDI-DI: 00884838088108
- Serial Numbers: 46002
- 46012
- 46013
- 46017
- 46018
- 46020
- 46021
- 46023
- 46025
- 46027
- 46029
- 46036
- 46039
- 46041
- 46042
- 46044
- 46053
- 46054
Distribution
Distributed nationwide across the United States.
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