Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
Philips is recalling Ingenia Ambition S and X MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing correct 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, and the defect results in incorrect data processing rather than a direct physical injury or hospitalization, fitting the criteria for a moderate severity issue.
Plain-English summary
Philips North America is recalling 422 Ingenia Ambition S and Ingenia Ambition X MRI systems, including specific model numbers and software versions R11, R12, and R13. The recall is due to a defect where diffusion tensor imaging (DTI) scans exported using the Enhanced MR DICOM format contain incorrect data regarding diffusion directions.
This defect affects the use of the exported data in conjunction with third-party software for tractography, such as mapping nerve fiber pathways in the brain. The incorrect data prevents the third-party software from correctly processing the DTI data for reconstruction. The affected units were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities should contact Philips North America for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 422
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): 781359 (S)
- UDI-DI: 00884838090057
- Serial Numbers: 48010
- 48023
- 48028
- 48047
- 48122
- 48160
- 48173
- 48180
- 48196
- 48286
- 2. Model Number (REF): 782108 (S)
- UDI-DI: 00884838098343
- Serial Numbers: 48507
- 48510
- 48530
- 48548
- 48554
- 48576
Distribution
Distributed nationwide across the United States.
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