Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 7
Pending LLM rewrite. Source: FDA_DEVICE Z-2204-2025.
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 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
- 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) 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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