Philips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
Philips is recalling six Ingenia Blue Seal MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate 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 specialized analysis, with no reported injuries, illnesses, or deaths in the source text, fitting the criteria for a moderate severity software defect.
Plain-English summary
Philips North America is recalling six Ingenia Blue Seal SE and Blue Seal XE MRI systems. The affected units are identified by model numbers 782185 (SE) and 782192 (XE) and software versions R11, R12, and R13. The recall covers specific serial numbers: 53002 for the SE model, and 56000, 56001, 56005, 56010, and 56012 for the XE model.
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.
The affected units were distributed worldwide, including in the United States and numerous international locations. The source text does not specify actions for consumers or patients, as the issue pertains to data export functionality for specialized imaging analysis.
The recalled product
- Product
- Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Affected units
- 6
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 (10)
- 1. Model number (REF): 1. 782185 (SE)
- UDI-DI: 00884838125698
- Serial Number: 53002
- 2. Model Number (REF): 782192 (XE)
- UDI-DI: 00884838128422
- Serial Numbers: 56000
- 56001
- 56005
- 56010
- 56012
Distribution
Distributed nationwide across the United States.
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