Philips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
Philips is recalling five SmartPath to MR 7700 units because diffusion tensor imaging 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, but the source text describes a data processing error that prevents correct reconstruction rather than a direct physical injury or hospitalization. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where no direct harm is reported.
Plain-English summary
Philips North America is recalling five units of the SmartPath to MR 7700 software, specifically models 782178 and 782207, running 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 diffusion direction data.
This defect affects users who export DTI scans and use 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 international locations.
No specific instructions for consumers are provided in the source text, but the recall indicates that the software's export functionality is compromised for specific imaging applications.
The recalled product
- Product
- SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Software
- Affected units
- 5
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 (9)
- 1. Model number (REF): 782178
- UDI-DI: 00884838122239
- Serial Numbers: 42165
- 42189
- 71081
- 2. Model Number (REF): 782207
- UDI-DI: 00884838128576
- Serial Numbers: 42055
- 42287
Distribution
Distributed nationwide across the United States.
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