Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.
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 accurate reconstruction rather than a direct physical hazard or reported injury. This aligns with the rubric for moderate severity involving functional defects without reported harm.
Plain-English summary
Philips North America is recalling 30 units of the Upgrade to MR 7700 software (Model number 782130, versions R11, R12, and R13). The recall affects units distributed worldwide, including the United States and numerous international locations.
The recall is due to a defect in the Enhanced MR DICOM export format. When diffusion tensor imaging (DTI) scans are exported using this 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.
Healthcare facilities and users of the affected software should stop using the Enhanced MR DICOM export for DTI scans until the issue is resolved. No specific instructions for remediation are provided in the source text, but users should contact Philips North America for further guidance.
The recalled product
- Product
- Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Affected units
- 30
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)
- Model number (REF): 782130
- UDI-DI: 00884838104402
- Serial Numbers: 42002
- 42030
- 42037
- 42066
- 42104
- 42151
- 42163
- 42164
- 42211
- 42219
- 42248
- 42376
- 45001
- 45007
- 45043
- 45044
- 45052
- 45179
Distribution
Distributed nationwide across the United States.
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