Philips Ingenia 3.0T MRI Systems Recalled for Potential Fire Risk
Philips is recalling 1,467 Ingenia 3.0T MRI systems worldwide due to potential gradient coil component failures that could produce smoke or fire.
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 potential fire and smoke hazards in MRI systems. No illnesses, injuries, property damage, or actual incidents are reported in the source; the hazard is described as potential rather than realized. Per the rubric, theoretical risks without reported harm score at most 3.
Plain-English summary
Philips is recalling 1,467 units of the Ingenia 3.0T magnetic resonance imaging system. These systems are distributed worldwide, including throughout the United States, and involve three specific model numbers with designated serial numbers.
The gradient coil component in these MRI systems may experience failures that could act as a heat source and potentially produce smoke or fire.
This is a Class II recall issued by the FDA. Healthcare facilities or other organizations operating affected Ingenia 3.0T systems should contact Philips for guidance on remediation options.
The recalled product
- Product
- Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- 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) 781342
- (2) 781377
- (3) 782103
- UDI-DI: (1) 00884838055339
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 71001
- 71002
- 71003
- 71004
- 71006
- 71007
- 71008
- 71010
- 71011
- 71012
- 71013
- 71014
- 71016
- 71018
Distribution
Distributed nationwide across the United States.
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