Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Pending LLM rewrite. Source: FDA_DEVICE Z-2210-2025.
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 Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
- 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) 781357
- (2) 782106
- (3) 782137
- (4) 782150 (China ONLY)
- UDI-DI: (1) 00884838088108
- (2) 00884838098329
- (3) 00884838108615
- (4) None
- Serial Numbers: (1) 46001
- 46002
- 46003
- 46004
- 46005
- 46007
- 46008
- 46011
- 46012
- 46013
- 46014
- 46015
Distribution
Distributed nationwide across the United States.
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