Philips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
Philips North America is recalling 131 MR 5300 systems because diffusion tensor imaging 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, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the defect results in data processing errors rather than direct physical harm.
Plain-English summary
Philips North America is recalling 131 units of the MR 5300 magnetic resonance imaging system. The affected models include 782110, 782152, 782156, and 782196, running software versions R11, R12, and R13. These systems were distributed worldwide, including in the United States and numerous international markets.
The recall is due to a defect in the Enhanced MR DICOM export format. When diffusion tensor imaging (DTI) scans are exported from these systems, the data contains incorrect diffusion directions. This error prevents third-party software from correctly processing the DTI data for tractography, which is used to map nerve fiber pathways in the brain.
Healthcare facilities and users of these specific MR 5300 systems should contact Philips North America for instructions on how to resolve the data export issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
The recalled product
- Product
- MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
- Manufacturer
- Philips North America
- Affected units
- 131
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): 782110
- UDI-DI: 00884838099364
- Serial Numbers: 63007
- 63027
- 63064
- 63076
- 63097
- 63123
- 63132
- 63137
- 63148
- 63150
- 63160
- 63236
- 63237
- 63238
- 63258
- 63300
- 63302
- 63360
Distribution
Distributed nationwide across the United States.
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