Philips MR 7700 MRI Systems Recalled for Incorrect DTI Data Exports
Philips is recalling 107 MR 7700 MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing accurate 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, but the source text describes a data processing error that prevents correct software reconstruction rather than a direct physical injury or hospitalization risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips North America is recalling 107 MR 7700 MRI systems (models 782120, 782153, 782155, and 782199) with 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 data error prevents third-party software from correctly processing the DTI data for tractography reconstruction, such as mapping nerve fiber pathways in the brain. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact Philips North America for instructions on how to address the software defect. Patients who have had DTI scans on these systems should consult their healthcare provider to determine if their imaging data requires re-evaluation or re-export using a different method.
The recalled product
- Product
- MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Affected units
- 107
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): 782120
- UDI-DI: 00884838104112
- Serial Numbers: 65000
- 65001
- 65002
- 65003
- 65004
- 65005
- 65006
- 65008
- 65009
- 65011
- 65012
- 65013
- 65014
- 65015
- 65016
- 65017
- 65018
- 65019
Distribution
Distributed nationwide across the United States.
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