Philips Ingenia MRI Systems Recalled for Incorrect DTI Export Data
Philips is recalling Ingenia 1.5T MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate processing by third-party software.
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, but the hazard is limited to data integrity errors in specific exports that prevent accurate third-party processing, with no reported injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips North America is recalling 216 Ingenia 1.5T, 1.5T CX, and 1.5T S MRI systems. The affected units are equipped with software versions R11, R12, or R13 and were distributed worldwide, including in the United States and numerous international markets.
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. This error prevents third-party software from correctly processing the DTI data for reconstruction, such as mapping nerve fiber pathways in the brain.
Healthcare facilities using these systems should contact Philips North America for instructions on how to resolve the issue. The defect affects data integrity for specific imaging exports but does not indicate a direct physical hazard to patients during the scanning process itself.
The recalled product
- Product
- Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Affected units
- 216
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. 781315 (1.5T)
- UDI-DI: 00884838099715
- Serial Numbers: 61005
- 61007
- 61014
- 61033
- 61036
- 61047
- 61056
- 61057
- 61076
- 61087
- 61088
- 61105
- 61116
- 2. Model Number (REF): 781341 (1.5T)
- UDI-DI: 00884838055322
- Serial Numbers: 70042
- 70051
- 70056
Distribution
Distributed nationwide across the United States.
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