Philips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
Philips is recalling Ingenia 3.0T 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 processing which may lead to diagnostic errors, but the source text does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Philips North America is recalling 243 Ingenia 3.0T and 3.0T CX MRI systems due to a software defect affecting data exports. The affected units are identified by specific model numbers (781342, 781377, 782103, and 781271) and software versions R11, R12, and R13.
The recall is necessary because when diffusion tensor imaging (DTI) scans are exported using the Enhanced MR DICOM format, the data contains incorrect diffusion directions. This error prevents third-party software from correctly processing the DTI data for tractography reconstruction, such as mapping nerve fiber pathways in the brain.
The affected units were distributed worldwide, including in the United States and numerous international markets. Healthcare facilities using these systems should verify their equipment against the provided serial numbers and contact Philips for corrective action.
The recalled product
- Product
- Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Affected units
- 243
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): 1. 781342 (3.0T)
- UDI-DI: 00884838055339
- Serial Numbers: 71001
- 71002
- 71008
- 71031
- 71038
- 71051
- 71061
- 71072
- 71084
- 71088
- 71089
- 71095
- 71101
- 71154
- 71163
- 71164
- 71166
- 71184
Distribution
Distributed nationwide across the United States.
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