MRI Gradient Coil Component Failure Risk: Potential Fire and Smoke Hazard
Philips Ingenia Elition X MRI systems may have gradient coil component failures that could generate heat, smoke, and fire. Affected units were distributed worldwide including the United States.
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 is an FDA Class II recall involving fire and smoke hazards from gradient coil component failure in an MRI system. However, the source text does not report any actual injuries, illnesses, or incidents—the hazard is theoretical. Per the rubric, risk-of-harm products without reported injuries score as High (3).
Plain-English summary
Philips North America is recalling affected Ingenia Elition X MRI (magnetic resonance imaging) systems due to a potential component failure in the gradient coil. This component failure may act as a heat source with a potential to produce smoke and/or fire.
The recalled systems include five model numbers (REF 781358, 782107, 782119, 782136, and 782151), encompassing 632 units. These devices were distributed worldwide, including throughout the United States and many other countries.
Healthcare facilities with affected MRI systems should verify whether their device is included in this recall by checking the device's model number and serial number against the FDA recall notice. The FDA and Philips have provided detailed serial number lists for each model to facilitate identification.
The recalled product
- Product
- Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke
- heat
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) 781358
- (2) 782107
- (3) 782119
- (4) 782136
- (5) 782151 (China ONLY)
- UDI-DI: (1) 00884838088115
- (2) 00884838098336
- (3) 00884838104129
- (4) 00884838108608
- (5) None
- Serial Numbers: (1) 42202
- 45000
- 45002
- 45008
- 45009
- 45010
- 45011
- 45023
- 45024
- 45025
Distribution
Distributed nationwide across the United States.
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