Philips Ingenia 3.0T CX MRI Systems Recalled—Potential Fire Hazard
Philips North America is recalling Ingenia 3.0T CX MRI systems worldwide due to potential gradient coil failures that may produce smoke and fire. About 350 units are affected.
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 FDA recall for MRI equipment with potential fire and smoke hazards from gradient coil component failures. No reported injuries, hospitalizations, or incidents are stated in the source text, making this a theoretical risk-of-harm scenario rather than a realized one. Per the severity rubric, this meets the criterion for High (score 3): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America is recalling Ingenia 3.0T CX magnetic resonance imaging (MRI) systems, model numbers 781271 and 782105. Approximately 350 units of these systems were distributed worldwide, including throughout the United States and numerous other countries.
The safety concern involves the gradient coil component of these MRI systems. Component failures in the gradient coil may act as a heat source with potential to produce smoke and/or fire.
This is a Class II FDA medical device recall, issued as recall number Z-2207-2025. The recall applies to specific serial numbers of both model types. Healthcare facilities and medical centers with affected units should refer to Philips North America for information on identifying affected equipment and available remediation options.
The recalled product
- Product
- Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
- 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) 781271
- (2) 782105
- UDI-DI: (1) 00884838068452
- (2) 00884838098312
- Serial Numbers: (1) 78000
- 78003
- 78004
- 78005
- 78007
- 78008
- 78009
- 78010
- 78011
- 78012
- 78013
- 78014
- 78015
- 78016
- 78017
- 78018
Distribution
Distributed nationwide across the United States.
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