Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Pending LLM rewrite. Source: FDA_DEVICE Z-2207-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The recalled product
- Product
- Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
- Manufacturer
- Philips North America
- Category
- Medical Device — Devices
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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