MRI System Gradient Coil Component May Overheat and Produce Fire or Smoke
Philips MRI systems with affected gradient coils may experience component failures that could produce smoke or fire. Fifteen units worldwide are affected.
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: FDA Class II recall with no reported injuries or hospitalizations. The hazard is theoretical—a potential component failure that may produce smoke or fire. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Philips North America is recalling SmartPath to dStream 3.0T MRI systems due to a potential component failure in the gradient coil. The affected component, identified by model number 782145, was distributed worldwide. Fifteen units with specific serial numbers have been identified as affected.
The gradient coil component may fail, creating a heat source capable of producing smoke and/or fire. While no incidents or injuries have been reported, the potential for this failure poses a safety risk in clinical settings where these devices operate.
Healthcare facilities currently using these MRI systems should identify whether they have affected units by checking their device serial numbers against the FDA recall notice. If you operate an affected device, contact Philips North America for instructions on inspection, repair, or replacement of the gradient coil component.
The recalled product
- Product
- SmartPath to dStream for 3.0T Model Number (REF): 782145;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke
- thermal-hazard
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 (17)
- Model Number (REF): 782145
- UDI-DI: 00884838108684
- Serial Numbers: 17377
- 17385
- 17435
- 34114
- 34208
- 38118
- 38127
- 38170
- 38294
- 38313
- 38336
- 73002
- 73004
- 74002
- 74004
Distribution
Distributed nationwide across the United States.
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