Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Pending LLM rewrite. Source: FDA_DEVICE Z-2206-2025.
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 Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
- 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) 781342
- (2) 781377
- (3) 782103
- UDI-DI: (1) 00884838055339
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 71001
- 71002
- 71003
- 71004
- 71006
- 71007
- 71008
- 71010
- 71011
- 71012
- 71013
- 71014
- 71016
- 71018
Distribution
Distributed nationwide across the United States.
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