Philips MR System Gradient Coil Failure May Produce Fire or Smoke
Philips is recalling certain SmartPath to Ingenia Elition X magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat and produce smoke or fire. Approximately 33 units are affected worldwide.
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: This recall addresses a potential risk-of-harm hazard where gradient coil component failure could produce fire and/or smoke. The FDA classified this as Class II, and the source text does not mention reported incidents or injuries, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling specific models of the SmartPath to Ingenia Elition X MR (magnetic resonance) system, including Model 782118 and Model 782144, due to a potential safety hazard involving the gradient coil component.
The gradient coil may fail and act as a heat source with potential to produce smoke and/or fire in the affected systems.
Approximately 33 affected units have been distributed worldwide, including throughout the United States and to numerous countries. Specific serial numbers have been identified as part of this recall.
Consumers or medical facilities with these systems should contact Philips North America or the FDA for further instructions or to determine if their device is affected.
The recalled product
- Product
- SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- gradient-coil-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) 782118
- (2) 782144
- UDI-DI: (1) 00884838099746
- (2) 00884838108677
- Serial Numbers: (1) 42049
- 42054
- 42072
- 42085
- 42098
- 42113
- 42158
- 42159
- 42160
- 42167
- 42194
- 42301
- 42306
- 42329
- 42340
- 71019
Distribution
Distributed nationwide across the United States.
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