Philips MRI Software Recall for Image Reconstruction Failure
Philips is recalling SmartPath MRI software due to a defect that can terminate examinations during image reconstruction if system memory is exceeded.
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 is a software malfunction that terminates examinations, which is a functional defect rather than a direct physical injury risk, and no injuries have been reported.
Plain-English summary
Philips North America LLC is recalling 965 units of SmartPath to dStream and SmartPath to Ingenia Elition X MRI software. The recall covers specific model numbers and serial numbers distributed worldwide, including the United States and numerous international markets.
The recall is due to a software issue that can cause an MRI examination to terminate during the image reconstruction process. This failure occurs if scan parameters are manually adjusted in a way that causes reconstruction requirements to exceed the available system memory.
Healthcare facilities using the affected software should contact Philips for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7.…
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Software
- Affected units
- 965
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 (System): 781260 (1.5T) UDI-DI: 884838095076
- Serial Numbers: 32953
- 8750
- 8554
- 9013
- 18574
- 18801
- 18988
- 20211
- 32923
- 32778
- 8156
- 8752
- 10139
- 10164
- 21379
- 21175
- 32445
- 11100
- 18583
Distribution
Distributed nationwide across the United States.
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