MRI System Gradient Coil Defects May Produce Fire or Smoke
Philips Ingenia 1.5T MRI systems are recalled due to potential gradient coil component failures that may produce smoke or fire. The recall affects 2,279 units distributed worldwide.
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: FDA Class II medical device recall for a risk-of-harm product (fire and smoke hazard from gradient coil component failure) where no illnesses or injuries have been reported. The hazard represents a real mechanism of device failure with potential for property damage and injury.
Plain-English summary
Philips North America has issued a recall of certain Ingenia 1.5T MRI systems due to a potential hazard in the gradient coil. Component failures in the gradient coil may act as a heat source and produce smoke and/or fire.
The recall encompasses 2,279 units that were distributed worldwide, including throughout the United States and in many other countries. The affected devices can be identified using the model numbers and serial numbers specified in the recall.
Healthcare facilities and imaging centers with Ingenia 1.5T MRI systems should determine whether their equipment is affected by comparing their device model numbers and serial numbers to those listed in the recall notice.
The recalled product
- Product
- Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- heat-source
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) 781315
- (2) 718641
- (3) 781396
- (4) 782101
- (5) 782115
- (6) 782140
- UDI-DI: (1) 00884838099715
- (2) 00884838055322
- (3) 00884838009820
- (4) 00884838098275
- (5) 00884838099043
- (6) 00884838108646
- Serial Numbers: (1) 61000
- 61001
- 61002
- 61003
- 61004
- 61005
- 61006
- 61007
Distribution
Distributed nationwide across the United States.
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