Philips Upgrade dStream Software Recall for Incorrect DTI Data Exports
Philips is recalling Upgrade dStream software versions R11-R13 because DTI scan exports contain incorrect diffusion direction data, preventing correct 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 that prevents accurate medical imaging reconstruction, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips North America is recalling the Upgrade dStream software (Model number 782127, versions R11, R12, and R13). The recall involves one unit distributed worldwide, including the United States and numerous international locations.
The recall is due to a defect in the software's handling of diffusion tensor imaging (DTI) scans. When exporting these scans using the Enhanced MR DICOM format, the software includes incorrect diffusion direction data. This error prevents third-party software from correctly processing the DTI data for tractography reconstruction, such as mapping nerve fiber pathways in the brain.
No injuries or illnesses have been reported in connection with this recall. Users should contact Philips North America for instructions on how to resolve the software issue.
The recalled product
- Product
- Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — Software
- Affected units
- 1
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 (3)
- Model number (REF): 782127
- UDI-DI: 00884838105591
- Serial Numbers: 65007
Distribution
Distributed nationwide across the United States.
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