Philips SmartPath MRI systems recalled due to potential fire hazard
Philips is recalling 294 SmartPath to dStream MRI systems due to potential component failures in the gradient coil that could produce smoke and fire. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with no reported injuries or hospitalizations. The hazard—component failure potentially causing fire or smoke—is theoretical but carries significant risk of harm, meeting the criterion for Score 3 (High): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America is recalling 294 SmartPath to dStream for XR and 3.0T MRI systems worldwide. The affected devices are identified by model numbers 781270, 782113, and 782129, along with specific serial numbers provided by the manufacturer.
The FDA has determined that component failures in the gradient coil of these systems may act as a heat source with the potential to produce smoke and/or fire. To date, no injuries or illnesses related to this issue have been reported.
Healthcare facilities and clinicians currently using these systems should contact Philips North America for further instructions regarding the remedy or potential replacement. The recall affects units distributed across the United States and more than 100 countries worldwide.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- component-failure
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 Numbers (REF): (1) 781270
- (2) 782113
- (3) 782129
- UDI-DI: (1) 00884838095083
- (2) 00884838098909
- (3) 00884838105805
- Serial Numbers: (1) 17006
- 17172
- 17204
- 17206
- 17212
- 17215
- 17222
- 17237
- 17239
- 17240
- 17242
- 17245
- 17246
- 17247
Distribution
Distributed nationwide across the United States.
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