Philips MRI Systems Recalled for Fire and Smoke Risk
Philips is recalling 50 Evolution Upgrade 3.0T MRI systems worldwide due to potential fire and smoke from gradient coil component failures.
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 for a risk-of-harm product involving potential fire and smoke hazard from medical equipment component failure. No reported injuries or incidents are mentioned in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Philips North America is recalling Evolution Upgrade 3.0T Magnetic Resonance (MRI) systems, Model Numbers 782117 and 782143. This is a Class II recall issued by the FDA due to a potential fire and smoke hazard.
The gradient coil component in these systems may experience failures that could act as a heat source, with a potential to produce smoke and/or fire.
Approximately 50 units have been identified and were distributed worldwide, including throughout the United States and more than 100 countries.
The recalled product
- Product
- Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
- Manufacturer
- Philips North America
- 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) 782117
- (2) 782143
- UDI-DI: (1) 00884838099739
- (2) 00884838108660
- Serial Numbers: (1) 42003
- 42023
- 42024
- 42029
- 42078
- 42217
- 42246
- 42375
- 42402
- 42408
- 71044
- 71348
- 71774
- 85146
- 85645
- 85663
Distribution
Distributed nationwide across the United States.
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