MRI System Gradient Coil May Produce Smoke or Fire
Philips is recalling 93 MRI systems with defective gradient coil components that may produce smoke or fire due to component failure.
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 a Class II recall involving potential fire and smoke hazard in a medical device with no reported incidents. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at most 3 (High).
Plain-English summary
Philips North America is recalling Evolution Upgrade 1.5T MRI (Magnetic Resonance Imaging) systems distributed worldwide due to a potential safety hazard. The gradient coil component in affected units may fail, acting as a heat source with the potential to produce smoke and/or fire.
The recall affects models with reference numbers 782116 and 782148. A total of 93 units have been distributed globally, including throughout the United States. Specific serial numbers for affected devices are available through the FDA recall notice.
No incidents, injuries, or hospitalizations related to this hazard have been reported. The FDA classified this as a Class II recall. Affected facilities should contact Philips North America for information regarding any recommended actions.
The recalled product
- Product
- Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
- Manufacturer
- Philips North America
- 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) 782116
- (2) 782148
- UDI-DI: (1) 00884838099722
- (2) 00884838108714
- Serial Numbers: (1) 41017
- 41024
- 41025
- 41041
- 41042
- 41047
- 41051
- 41080
- 41089
- 41130
- 41139
- 41143
- 41144
- 41179
- 41189
- 41196
Distribution
Distributed nationwide across the United States.
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