Philips Ingenia Elition S MRI Systems Recalled for Fire Hazard
Philips is recalling 242 Ingenia Elition S MRI systems worldwide due to potential gradient coil component failures that could produce smoke and fire. Affected facilities should immediately stop using the systems.
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 FDA Class II recall involves a high-risk hazard (potential fire and smoke from component failure in a medical device used in clinical settings) but with no reported illnesses, injuries, or hospitalizations. Per the severity rubric, recalls involving risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
Philips North America is recalling 242 Ingenia Elition S magnetic resonance imaging (MRI) systems distributed worldwide. The recall is due to a potential defect in the gradient coil component that may fail and act as a heat source, creating a risk of smoke and fire.
The affected units include Model Numbers 781357, 782106, 782137, and 782150, with specific serial numbers provided by the manufacturer. Systems were distributed in the US and to multiple countries internationally.
Affected healthcare facilities should immediately cease operation of recalled MRI systems. Philips has notified users directly. For remediation instructions and additional information, users should contact Philips North America or review the FDA recall notice (Z-2210-2025).
The recalled product
- Product
- Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke
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) 781357
- (2) 782106
- (3) 782137
- (4) 782150 (China ONLY)
- UDI-DI: (1) 00884838088108
- (2) 00884838098329
- (3) 00884838108615
- (4) None
- Serial Numbers: (1) 46001
- 46002
- 46003
- 46004
- 46005
- 46007
- 46008
- 46011
- 46012
- 46013
- 46014
- 46015
Distribution
Distributed nationwide across the United States.
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